Taylor v. Canada | Feb 27, 2020

CITATION: Taylor v. Canada (Attorney General), 2020 ONSC 1192

COURT FILE NO.: CV-181819

DATE: 20200227

ONTARIO

SUPERIOR COURT OF JUSTICE

)

BETWEEN:

KATHRYN ANNE TAYLOR

) John Legge, Steve Pengelly, David Steeves,

) and Brian Moher for the Plaintiff

Plaintiff

)

– and –

)

Sean Gaudet, James Soldatich, Andrew Law,

James Gorham, Roger Flaim, for the

Defendant

THE ATTORNEY GENERAL OF

CANADA

Defendant

James Newland, Neil Wilson for the Ontario

Health Insurance Plan

) HEARD: April 1-3, 5, 8-12, 23-26, 29, 30;

) May 1-3, 6-12, 15, 23-26. 29-31; June 3-5,

) 10-13, 17-21; September 16-20, 23; October

) 7-9, 2019

LEDERER J.

INTRODUCTION

[1]

Government regulates many areas of our lives. This regulatory activity is part of what

organizes our society, confirms its values and, in some circumstances, gives direction to what we

can, should or might do. In a culture which values the individual and encourages other

participants (say universities, research entities and corporations) to find solutions to common

concerns, locating the balance between public and private responsibility when things go wrong is

a complicated problem. This case enters into this difficult question but in what turns out to be a

limited way.

[2]

The area being regulated is a form of medical treatment, not the activity of the

professionals involved (doctors and nurses), or the use of drugs but instead so called “devices”

that may improve the circumstances of those in need of relief. This includes, for example, any

apparatus that may be used to augment the structure of the body and improve its function. In this

Page: 2

case, Vitek Inc., a corporation located in Houston, Texas was promoting and selling a proprietary

product (“Proplast”) for a variety of uses associated with an array of physical issues of concern

to many people. Of particular relevance was its use in implants designed to replace the meniscus

in the jaw to alleviate discomfort and improve performance. This occurred at a time of growing

government interest in the entry of these devices into the market and the perceived need for

increased regulation to meet their arrival. Devices using Proplast were implanted into some

Canadian citizens. Today, it is generally accepted that Proplast is frangible (fragile, brittle),

breaks down and that the resulting particles may distribute themselves causing much suffering

and pain such that the use of the jaw may become restricted, in some cases ineffectual. The

Plaintiff says that the defective nature of the product was well-known and understood long

before these implants were put in place. It is said that the fault for the harm that resulted lies, in

part, with the government for its failure to properly regulate and control the entry of Proplast

products into the market and its failure to respond appropriately after the difficulties of the

recipients of these implants became apparent.

HISTORY OF THIS ACTION

[3]

This is a class action. It has a history, not a happy one. The implants which mark the

beginning took place at some point between 1983 and 1990. This action was commenced in

1999. It has taken 20 years to bring it to trial. By my count, from the trial record, with the

delivery of these reasons, no fewer than 23 judicial officers (Masters, Superior Court and Court

of Appeal judges) will have touched this proceeding.

[4]

The initial representative plaintiff was Judith Logan. In 2002 an effort was made to add,

as a plaintiff, Wendy Bulloch-MacIntosh. She had commenced an individual action. The stated

purpose of the motion was to add to the certification record information elicited from

representatives of the Crown during the discovery in that separate proceeding. There was a

threshold issue. Could the individual action be stayed but left in place if Wendy Bulloch-

MacIntosh became a representative plaintiff in the class action? Initially, the judge considering

the matter indicated a willingness to hear further submissions. In the end, the plaintiff withdrew

the request.¹In 2003, Judith Logan was replaced by Kevan Drady and the present representative

plaintiff, Kathryn Anne Taylor.²Kevan Drady withdrew in 2006 to commence a separate class

action alleging negligence over the regulation, by Health and Welfare Canada, of a different

implant, that one using “silastic” (a combination of silicone and plastic), not Proplast. That

action was struck out by the Court of Appeal in 2008 for failing to disclose a reasonable cause of

action.³

¹Trial Record at T. 11 and T. 12 (Endorsements of Mr. Justice Winkler respectively dated February 13, 2002 and

May 15, 2002.)

²Ibid at T. 13 and T. 14 (Respectively the Reasons and Order of Mr. Justice Winkler.)

³Drady v. Canada, 2008 ONCA 659 (CanLII), 300 DLR (4th) 443, 270 OAC 1, 68 CPC (6th) 306, [2008] OJ No

3772 (QL), 169 ACWS (3d) 683

Page: 3

[5]

The first substantive issue that comes to mind is whether, given the time lapse, the action

was commenced outside the applicable limitation periods. At the time, there were two limitations

that could have impacted this case. The first, 6 years as found in the Limitations Act⁴, and the

second the Crown Liability and Proceedings Act⁵which, in turn, adopted whatever provisions

applied in the province where the cause of action arose being, in this case, the Proceedings

6

Against the Crown Act of Ontario. That Act required that at least 60 days before the

commencement of an action against the Crown a notice of the claim be served on the Crown.

The issue of applicable limitations arose as part of a motion heard considering the substitution of

the original representative plaintiff. The question was whether the substitution could not take

place because, in the absence of certification, the putative class action remained an individual

action. This would mean that the “tolling” of the applicable limitation period through the Class

Proceedings Act, 1992⁷had not become effective. The motion judge did not accept this

submission. In any case, as he saw it, there was no need to start a new action. “The most

appropriate approach to deal with the motion to substitute in the present circumstances is by way

of amendment, pursuant to the jurisdiction granted to the court under ss. 12 and 14 of the CPA

[Class Proceedings Act] rather than for the new representative plaintiffs to commence a fresh

proceeding.”⁸Apparently, the issue of whether the action as commenced in the name of Judith

Logan was out of time did not come up. However, it did in the appeal that followed:

In any event the motion judge did not deal with that argument and I can only

assume it was because the argument was not put in that way. In any event,

however it is clear from the disposition made by the motion judge that because the

claim is that the breaches by the appellant are continuing, the action was not, on

its face, barred by the passing of the limitation period.⁹

[6]

of whether this action was out of time has not been raised since. It was not raised at this trial.

The appeal was dismissed. The substitution was allowed.¹⁰So far as I am aware the issue

[7]

The certification of this action as a class proceeding was not finalized until July 6, 2012

following a determination made by a five-judge panel of the Court of Appeal. What did it take to

get to that point? During May, 2000, the plaintiff (still Judith Logan) brought a motion to certify

the action as a class proceeding.¹¹On October 3, 2000, a motion to strike certain materials

included in the Motion Record filed, by the Plaintiff, in support of the motion to certify the

action was heard. Of the six contested items, two were withdrawn, three were struck and for one,

the issue declared moot.¹²

⁴R.S.O. 1990, c. L.15

⁵R.S.C., c. C-50

⁶R.S.O. 1990, c. P. 27

⁷S.O. 1992, c. 6, s. 28

⁸Trial Record at T. 13 (Endorsement of Mr. Justice Winkler at paras. 14-25 (The sentence quoted is at para. 25))

⁹Logan v Canada (Minister of Health) 2004 Canlli 184 (ON CA), 71 OR (3d) 451, 188 OAC 294 at para. 15

¹⁰Ibid and Trial Record at T. 19 (Respectively the Decision and Order of the Court of Appeal both of June 29, 2004)

¹¹Trial Record at T. 7 (Endorsement of Master MacLeod dated July 25, 2001) at para. 12

¹²Ibid at T. 4 and T. 5 (Respectively, the handwritten endorsement and Order of Mr. Justice Winkler dated October

3, 2000.)

Page: 4

[8]

On July 25, 2001, Master MacLeod dealt with a motion, generally, concerning the refusal

to answer questions during a cross-examination conducted in preparation for a motion to amend

the pleadings. What is apparent is that the difficulties that have marked the overall conduct of

this action had already appeared:

A form of procedural gridlock has arisen over this issue notwithstanding

admonitions by the case management judge.¹³

[9]

An appearance was necessary to settle the order. The difficulties that had presented

themselves continued. The Master was required to underscore that the order he had made

required the deponents to the affidavits to reattend to answer the questions asked, as well as

reasonable follow-up questions. As the Master noted, while the issue of a re-attendance is

discretionary, the permission to permit a subsequent examination was, and remains, the “usual

order”. The Master felt the need to go on:

I find it an extraordinary submission that the credibility of these witnesses will

remain an issue on the motion.¹⁴

[10] It seems the Master also had to consider and deal with an allegation of some sort of

improper conduct of counsel for the Plaintiff:

I do not view the affidavits provided by Mr. Legge as an improper attempt to

unilaterally determine the mode of examination but rather as an attempt to provide

timely answers in a cost effective manner.¹⁵

[11] The Master noted the Crown’s response to whatever problem it saw:

Nevertheless, the Crown insists on proceeding orally and there has been no

persuasive argument why this should not be allowed.¹⁶

[12] This all has to do with a refusals motion. One has to wonder why all this obfuscation was

thought to be necessary.

[13] The certification motion was considered in reasons delivered on September 5, 2007. The

action was certified:

The allegations are consistent with an interpretation that Health Canada's failure

to take steps to enforce the regulations and its directions to the distributor of the

devices - despite its knowledge that they were being breached - facilitated the

¹³Ibid at T.7 (Endorsement of Master MacLeod dated July 25, 2001 at para. 12.)

¹⁴Ibid at T.10 (Endorsement of Master MacLeod dated October 9, 2001, p. 2.)

¹⁵Ibid at T. 10, p. 2

¹⁶Ibid at T. 10, p. 2

Page: 5

continued sale of the devices and thereby created a risk to the health of the

intended recipients. Health Canada’s alleged failure to enforce the regulations

when it was aware that sales of the implants were continuing after it had given

notice of breaches on a number of occasions over a period of six or seven years,

could only have encouraged the importer/distributor to believe that it could ignore

its statutory obligations, and Health Canada’s warnings, with complete impunity.

In these circumstances, I believe it would be open to a court to find that Health

Canada’s course of conduct – including the dissemination of the misinformation

in its database - increased the risk to the health of the plaintiff and other potential

recipients of the implants and gave rise to a relationship of proximity with them.¹⁷

[14] The Court pointed out the limits of this determination:

It is possible that the plaintiff will not be able to prove the allegations of fact in

the statement of claim - or that a different complexion may be placed on them

when all the evidence on each side is before the court at trial. These are not

matters I am concerned with on this motion.

[15] But went on to confirm the then pertinent conclusion:

On the basis of the pleading alone, I do not consider it to be plain and obvious that

Ms. Taylor has no chance of success in establishing that a relationship of

proximity – as required to establish a private law duty of care – existed in

connection with operational acts of Health Canada. I believe this conclusion is

consistent with the cases I have cited, and others…¹⁸

[16] A motion was brought to the Divisional Court seeking leave to appeal the order certifying

the class action. Leave was refused.¹⁹

[17] This was not the end of the Court considering the question of certification of the

proceeding as a class action.

[18] A year after the certification motion, the Court of Appeal released its decision in Drady v.

Canada.²⁰It too considered implants to the jaw. In that case, in this Court, the year before, the

same judge, as on the certification motion, had struck the Statement of Claim. Proximity was not

apparent because the plaintiff was unable to identify the particular implant he had received as

being manufactured by Vitek Inc.:

¹⁷Taylor v. Canada (Health), 2007 CanLII 36645 (ON SC), 285 DLR (4th) 296, 49 CPC (6th) 36, [2007] OJ No

3312 (QL), 160 ACWS (3d) 385 at para. 39

¹⁸Ibid at para. 40. (The other citations referred to at the end of the quotation are: Sauer v. Canada (Attorney

General),2007 ONCA 454 (CanLII), [2007] O.J. No. 2443 (C.A.); Swanson Estate v. The Crown (1991), 1991

CanLII 8226 (FCA), 80 D.L.R. (4^th) 741 (F.C.A.); and Williams v. Canada (Minister of Health) (2005), 2005 CanLII

29502 (ON SC), 76 O.R. (3d) 763 (S.C.J.))

¹⁹Taylor v. Canada (Attorney General), 2007 CanLII 55708 (ON SCDC), 289 DLR (4th) 567, 233 OAC 111, —

[2007] OJ No 4947 (QL), 163 ACWS (3d) 368

²⁰Supra (fn. 3)

Page: 6

In these circumstances – independently of any other considerations - the facts

alleged with respect to the Crown's operational negligence with respect to the

Vitek Proplast implants are, in my judgment, insufficient to give rise to

relationship of proximity between it and Mr Drady. Under the FDA and the

regulations, the Crown does not regulate devices generically or by categories. Its

powers and responsibilities are confined to dealing with particular devices sold, or

to be sold, in Canada on a case by case basis. The Crown's alleged negligence in

respect of the defaults of the Vitek Proplast implant vendor cannot create

proximity with Mr Drady if it is not alleged that he received such a device.

Independently of any other consideration, a causal relationship between the

plaintiff, the device and its vendor is an essential link in the creation of a

relationship of proximity. …²¹

[19] The device implanted in Kevan Drady did not use or contain Proplast. It relied on silastic.

The Court of Appeal in Drady considered the Superior Court decisions in both that case and this

one. It confirmed the decision that, in Drady, there was no proximity between the Crown and the

plaintiff. There being no proximity, it was plain and obvious that the action could not succeed.

[20] At about the same time as the decision of the Court of Appeal in Drady v. Canada it also

released its reasons in Attis v. Canada²²which considered the same issues, albeit in relation to

breast implants rather than jaw implants. The legislative scheme did not demonstrate any

intention to impose a private law duty of care²³and there was no direct communication or

interaction between the government and the plaintiff in relation to the operation or

implementation of a policy such that a duty of care could arise. There was no allegation of any

representations by Health and Welfare Canada that were capable of supporting a relationship of

proximity.²⁴

[21] Both Drady and Attis made reference to Sauer v. Canada (Attorney General).²⁵It runs

counter to their determination concerning the absence of proximity. In Sauer, a farmer

commenced a class action as a result of a cow, in Alberta, contracting “BSE” (colloquially “Mad

Cow Disease”). Some countries closed their borders to Canadian beef. The law suit was for

negligent regulation of the cattle industry and claimed for the financial losses suffered as a result.

In certifying the action, the judge considering the motion held that a duty of care had been

disclosed in the pleadings. The Court of Appeal made this observation even though the judge had

not directly addressed the question.²⁶The motion judge had moved directly to the issue of

²¹Drady v. Canada, 2007 CanLII 27970 (ON SC), [2007] CarswellOnt 4631, [2007] OJ No 2812 (QL), 159

ACWS (3d) 177 at paras. 23 and 24

²²2008 ONCA 660 (CanLII), 93 OR (3d) 35, 300 DLR (4th) 415, 254 OAC 91, 59 CPC (6th) 195, [2008] OJ No

3766 (QL) , 169 ACWS (3d) 684

²³Attis v. Canada (Health), supra (fn. 22) at para. 62

²⁴Ibid at para. 66 and 68

²⁵Sauer v. Canada (Attorney General), 2007 ONCA 454 (CanLII), 225 OAC 143, 31 BLR (4th) 20, 49 CCLT (3d)

161, [2007] OJ No 2443 (QL), 159 ACWS (3d) 306

²⁶Taylor v Canada (Health), 2010 ONSC 4799 (CanLII), 81 CCLT (3d) 106, [2010] OJ No 5936 (QL) at para. 30

Page: 7

whether there was a policy rationale for overriding the finding of proximity and the resulting

duty of care as required by the second stage of the test in Anns v. Merton London Borough

Council.²⁷In Sauer v Canada (Attorney General) the Court of Appeal upheld the certification. It

dealt with the issue of proximity in a single paragraph:

On the other hand, Sauer argues that he has pleaded the facts required to show

sufficient proximity between Canada and commercial cattle farmers to raise

a prima facie duty of care. In particular, he points to the many public

representations by Canada that it regulates the content of cattle feed to protect

commercial cattle farmers among others. He says this shows that Canada was

acting with their interests in mind rather than the broad public interest. Sauer says

that Canada’s public assumption of a duty to Canadian cattle farmers to ensure the

safety of cattle feed yields the conclusion that it is not plain and obvious that his

claim of a prima facie duty of care will not succeed. I agree.²⁸

[22] Drady and Attis having been decided and based on what they determined, the Crown

moved, in this action, to strike the Statement of Claim and decertify the class action. The Court

determined that the pleading failed to disclose a reasonable cause of action but granted the

plaintiff leave to amend the Statement of Claim. The Court denied the motion to decertify the

class action.²⁹

[23] In coming to its decision, the Court took account of how each of Drady and Attis dealt

with Sauer:

The treatment of Sauer in these cases is typified by the following comments

in Attis and Drady:

[In Sauer] this court found a sufficient pleading of proximity at

para. 62 on the basis of the many express "public representations

by Canada that it regulated cattle feed to protect commercial cattle

farmers among others" (emphasis added). Accordingly, the

result in Sauer depended on the allegation of specific

representations by the Government that it was acting in the

interests

of

the

plaintiffs.

On

this

basis, Sauer is

distinguishable because the appellants in this case do not plead any

specific representations by Health Canada that it was acting to

protect the particular interests of the consumers of breast implants.

(Attis at para 49)

27

[1977] UKHL 4, [1978] AC 726 (The test established in Anns v. Merton London Borough Council, though later

rejected in England, is still relied on in Canada. It is a broad test for determining the existence of a duty of care. The

test has two stages. It requires first a “sufficient relationship of proximity based upon foreseeability”; and secondly

considerations of reasons (policy) why there should not be a duty of care.)

²⁸Sauer v. Canada (Attorney General), supra (fn. 25) at para. 62

²⁹Taylor v Canada (Health), supra (fn. 26) at paras. 26, 49, 54 and 76

Page: 8

Proximity was also adequately pleaded in Sauer on the basis of the many express

public representations by the government that it was acting for the explicit

purpose of protecting the commercial cattle farmers. These representations

supported the plaintiff’s allegation that the government assumed a private law

duty to act on behalf of the farmers. (Drady at para 42)³⁰

[24] And concluded:

The significance attributed to the representations in Sauer would appear to have

considerable precedential importance for counsel and motions judges when

considering the kind of representations by the Crown that could give rise to a

sufficiently close relationship with the plaintiff.³¹

[25] In the end it was not plain and obvious that the proximity necessary to demonstrate a

private duty of care could not be met:

In these circumstances, I believe I should accept the amended pleading on the

ground that – when it is read generously - it is not plain and obvious that a finding

of proximity could not be made at trial if the factual allegations pleaded are

proven. At the very least, in view of the need for clarification of the requirements

for an effective public assumption of a private law duty of care, I consider

that this is a case in which it should be held that the particular issue on which

proximity turns is not fully settled in the jurisprudence within the meaning of the

decisions cited in paragraph 47 above. In such cases it has been held that the issue

in dispute is best left to be dealt with at trial on the basis of a full evidentiary

record.³²

[26] Instead of proceeding to the Divisional Court and recognizing the confusion the mix of

cases then extant had caused, the Crown determined to move directly to the Court of Appeal. A

motion was brought for leave to have a special case determined. The judge opened his reasons

observing that “[t]his action has had a tortured history”.³³It was 10 years after the action had

been commenced. There had been no progress. The motion was granted, in part out of concern

for the delay:

The parties have indicated to me that this litigation has already become a

procedural marathon. If the case was to follow through the normal course in the

Divisional Court with leave to appeal and appeal in the Divisional Court,

followed by the inevitable application for leave to appeal to this court and the

appeal in this court, then several more months -- if not a couple of years -- will

³⁰Taylor v Canada (Health), supra (fn. 26) at para. 35

³¹Taylor v Canada (Health), supra (fn. 26) at para. 37

³²Taylor v Canada (Health), supra (fn. 26) at para. 73

³³Taylor v. Canada (Attorney General) 2011 ONCA 181, 104 OR (3d) 481, 277 OAC 126, [2011] OJ No 949 (QL).

(A Notice seeking leave to appeal to the Divisional Court, dated September 15, 2010 was filed but no action taken

pending the outcome of the motions seeking a special case (at para. 19).)

Page: 9

have passed. This action was commenced in December 1999 and pleadings have

not yet closed. So much for access to justice!

It is time to get this case moving ahead…³⁴

[27] It is this order that placed the matter before the panel of five judges of the Court of

Appeal. In its decision the Court of Appeal picked up on the general understanding outlined in

Attis to the effect that the proximity necessary to found a duty of care can arise from the

legislation or through direct interaction between the regulator and the individuals impacted:

The approach taken to the claims in Drady and Attis is consistent with that

described above. In both cases, this court looked first at the relevant legislative

scheme and found that it imposed no private law duty of care: see Attis, at

paras. 53-62; Drady, at paras. 37-39. The court then turned to the pleadings in

each case to determine whether the interactions between the regulator and the

plaintiff set forth in the pleadings created a relationship of proximity such as to

justify a finding of a prima facie duty of care.³⁵

[28] The Court rejected the finding, apparent in the determination in Sauer, that the “many

public representations” made by the regulator as to its intention to protect farmers was sufficient

to support a finding of the proximity required as the basis for the existence of a duty of care:

In my view, a finding of proximity based entirely on a regulator's public

acknowledgement of its public duties to those affected by its actions, coupled

with reliance by those affected on the regulator's public statements, is inconsistent

with the Supreme Court's rejection in Imperial Tobacco of the claim that Health

Canada owed a private law duty of care to consumers of low-tar cigarettes

because it had made public representations as to the relative safety of those

cigarettes.³⁶

[29] The Court concluded:

This is not the time or place to pass upon the ultimate sufficiency of the

pleadings in Sauer. I am satisfied, however, that the detailed analyses of

proximity in Attis and Drady, particularly in the light of the subsequent judgment

in Imperial Tobacco, are more in line with the prevailing jurisprudence. The

single conclusory observation in Sauer, standing alone, is not consistent with that

jurisprudence.³⁷

³⁴Ibid at paras. 27-28

³⁵Taylor v. Canada (Attorney General), 2012 ONCA 479 (CanLII), 111 OR (3d) 161, 352 DLR (4th) 690, 293

OAC 312, 95 CCLT (3d) 88 at paras. 92

³⁶Ibid at para 95

³⁷Ibid at para. 97

Page: 10

[30] However, the Court of Appeal was not prepared to foreclose the possibility of the

required proximity being available to the Plaintiff. The inquiry is broader than looking for

immediate and direct interaction between the regulator and the prospective plaintiff:

Where the legislation is not determinative one way or the other, the courts explore

the specific circumstances of the interactions between the regulator and the

plaintiff in the context of the legislative scheme to decide whether a sufficiently

"close and direct" relationship exists to justify the imposition of a prima facie

duty of care…³⁸

[31] The Court addressed the substance of that inquiry:

Findings of proximity based on the interactions between the regulator and the

plaintiff are necessarily fact-specific. The jurisprudence does, however, suggest

there are two important factual features in those cases where the court has found a

prima facie duty of care.³⁹

[32] And explained the two factual features it found important:

First, the facts demonstrate a relationship and connection between the regulator

and the individual that is distinct from and more direct than the relationship

between the regulator and that part of the public affected by the regulator's

work.⁴⁰

And

The second feature of those cases in which the courts have found that the

interactions between the plaintiff and the regulator created a prima facie duty of

care arises out of the nature of the duty actually imposed by the legislative

scheme. While the statutory duties are found to be public duties and not,

therefore, themselves the basis for any private law duty of care, those public

duties have been found to be consistent with the existence of a private law duty of

care owed to an individual plaintiff.⁴¹

[33] On this basis the Court concluded:

³⁸Ibid at para. 79 referring to R. v. Imperial Tobacco Canada Ltd., [2011] 3 S.C.R. 45, [2011] S.C.J. No. 42, 2011

SCC 42 (CanLII), at para. 50; Hill v. Hamilton-Wentworth Regional Police Services Board, [2007] 3 S.C.R.

129, [2007] S.C.J. No. 41, 2007 SCC 41 (CanLII), 285 D.L.R. (4th) 620, at paras. 26-45; Fullowka v. Pinkerton's of

Canada Ltd., [2010] 1 S.C.R. 132, [2010] S.C.J. No. 5, 2010 SCC 5 (CanLII), at paras. 37-55; Heaslip Estate v.

Mansfield Ski Club Inc. (2009), 96 O.R. (3d) 401, [2009] O.J. No. 3185, 2009 ONCA 594 (CanLII), 310 D.L.R.

(4th) 506, 67 C.C.L.T. (3d) 1, 252 O.A.C. 1, 179 A.C.W.S. (3d) 1224 at paras. 15-31.

³⁹Ibid at para. 80

⁴⁰Ibid at para. 80

⁴¹Ibid at para. 88

Page: 11

The jurisprudence permits no definitive answer for the first question. As counsel

for AG Canada put it in his factum, "[t]he requirements for proximity are diverse

and depend on the facts of each particular case".⁴²

[34] The Court of Appeal did not stop there:

…there is no allegation of any direct contact between the plaintiff [Kathryn

Taylor] and Health Canada⁴³

[35] However, the possibility of proximity remained:

…In my view, it is arguable that the misrepresentations, combined with the failure

to correct that misrepresentation in the face of knowledge of the serious and

ongoing risk posed to a clearly definable and relatively small group of consumers,

could be viewed as akin to the regulator's failure in Fullowka to act in the face of

the known and ongoing dangers posed to the small and well-defined group of

miners who worked in the specific mine which the regulator knew to be unsafe.⁴⁴

[36] With this, the action was certified and proceeded as a class action.

[37] Why review this history now? It is unacceptable that it has taken as long as it has for this

action to proceed to trial. The case is premised on the idea that there is a group of people who

have been harmed by the alleged neglect of the government. They have been waiting for twenty

years, their suffering continuing, presumably with the hope, maybe even the expectation, of

some assistance. No one should be content with the time this has taken. Those involved have to

ask why they allowed this to happen. Moreover, what the reasons of the Court of Appeal

demonstrate is that the foundational question to be answered: Did the government owe the

members of the class a private duty of care, is a limited one. No duty of care is imposed by the

legislation. Nor, in this situation, is there proximity as a result of direct and immediate

interaction. What is left is narrow. Is there some identifiable group to which, as a result of some

action by the government, proximity exists and a duty of care attaches?

[38] This is not the only limitation imposed through the history of this unfortunate litigation.

[39] It should go without saying that there are other parties who would have been involved in

the importing, marketing, selling, purchasing, implanting and observing the results of any

surgery associated with the placing of Vitek Proplast devices. These would include the

manufacturer, the distributor, the hospital and various doctors and other professionals. Not

surprisingly, given that the only defendant in this action is the Crown, it issued Third Party

Claims. The Trial Record includes an order, dated September 14, 2006, allowing the Crown, on

consent, to deliver its Amended, Amended, Amended, Amended Third Party Claim.⁴⁵There is

⁴²Ibid at para. 92

⁴³Ibid at para. 107

⁴⁴Ibid at para. 111

⁴⁵Trial Record at T. 23

Page: 12

no earlier form of the Third Party Claim in the Trial Record. Clearly, it had been subject to a

series of changes. There is another order, this one issued on September 25, 2005, as I read it, in

furtherance of the amendment allowed 10 days earlier. It allowed for the discontinuance of the

Third Party action against those that, with the amendments that had been ordered in place, were

no longer the subject of any allegations in the Third Party Claim.⁴⁶

[40] The motion that determined that, in Drady, the Statement of Claim disclosed no

reasonable cause of action was joined by a motion to strike the Third Party Claims in both Drady

and this case. The question that arose concerned what the Plaintiff was claiming and, in

particular, did it leave open the prospect that the Crown, if found liable, could have a claim to

contribution and indemnity as allowed for by the Negligence Act.⁴⁷At the outset, counsel for the

Plaintiff was insistent that the Plaintiff’s claim perceived that the Crown was liable for all of the

damage she had suffered. Counsel for the moving parties (the Third Parties) relied on “a few

references to the Crown’s several liability that appeared in the Plaintiff’s pleadings”.⁴⁸The Court

determined that “several” liability did not foreclose the possibility of contribution from others:

I do not believe there is any doubt that the great majority of situations in which a

right to contribution arises in practice involve several, rather than joint,

tortfeasors.⁴⁹

[41] On this basis, one would expect that the motion was dismissed. It was. But not before

counsel for the Plaintiff had a change of heart. On a subsequent appearance, counsel indicated a

willingness to make clear that while the position remained that the Crown was liable for all the

damage suffered, should it be found that others shared the blame, the Plaintiff was seeking an

award only for the Crown’s proportionate share. This being so there would be no basis for a

claim for contribution. The motion was dismissed but on the understanding that it was open to

the Plaintiff to amend the Statement of Claim to make clear that the liability of the Crown was

limited to its relative degree of fault. An application could then be made for a declaration with

respect to that relative degree of fault.

[42] The order was appealed. By the time the appeal was heard, the Statement of Claim had

been amended to meet the suggestion of the motion judge. Thus, there was no basis for a claim

⁴⁶Ibid at T. 24

⁴⁷R.S.O. c. N.1 Section 1 states:

Where damages have been caused or contributed to by the fault or neglect of two or more

persons, the court shall determine the degree in which each of such persons is at fault or

negligent, and, where two or more persons are found at fault or negligent, they are jointly and

severally liable to the person suffering loss or damage for such fault or negligence, but as

between themselves, in the absence of any contract express or implied, each is liable to make

contribution and indemnify each other in the degree in which they are respectively found to be at

fault or negligent.

⁴⁸Drady v. Canada, supra (fn. 21) at para. 62

⁴⁹Ibid at para. 64

Page: 13

for contribution. The appeal was dismissed. The Court of Appeal took it that the motion judge

had struck the Claim and that he was right to do so.⁵⁰

[43] This is another limitation as to what can be accomplished in this trial. The Court of

Appeal, in dealing with the Third Party claim, observed that the Court maintains the jurisdiction

to apportion fault against a person not a party to the action or, as put by the Court of Appeal:

“…nothing in the language of s. 1 [of the Negligence Act⁵¹] precludes a court from doing so.”⁵²

No one is asking for this kind of apportionment. In this situation it would not be appropriate as a

common issue. The answer would be, or could be, different for every member of the class

depending on who was involved and what role they played. Thus, all that can happen in this

common issues trial is the recognition that there was a duty of care owed and that it was, or was

not, breached. Nothing can be done to assess the degree of fault or the proportion of the liability

attributable to any party. Still it seems not unreasonable to propose, as a possibility, that once

any liability of the manufacturer, distributor, doctors, hospitals and others are accounted for, any

degree of liability attributable to the government might be small, in relative terms and as to its

value.

[44] Another limitation is in respect of the class. How many people are there who could

benefit from a finding in favour of the class? Not many.

[45] How was the class to be defined?

…The classes that the plaintiffs seek to represent consist of persons resident in

Canada, outside British Columbia and Quebec, who received the TMJ implants.⁵³

[46] This is a highly generalized statement. A true understanding of the class requires

refinement. I begin by repeating that the reason Kevan Drady’s individual action failed is

because he was unable to identify Vitek Inc. as the manufacturer of the implant he had received:

In this case, although the allegations relied on by the plaintiff appear to relate to

the same implants (Vitek Proplast implants) of the same vendor/importer whose

breaches of duty were allegedly ignored by the Crown in Baric, it is not pleaded

that Mr. Drady received any such implant.⁵⁴

[47] This class action concerns those who received Vitek Inc. Proplast temporomandibular

joint (jaw) implants. What follows from Drady is that if the individual did not receive one of

these implants, he or she cannot be a member of the class:

⁵⁰Taylor v. Canada (Health), 2009 ONCA 487 (CanLII), 95 OR (3d) 561, 309 DLR (4th) 400, 264 OAC 229,

[2009] OJ No 2490 (QL)

⁵¹R.S.O. 1990 c N.1

⁵²Taylor v. Canada (Health), supra (fn. 50) at para. 27

⁵³Drady v. Canada, supra (fn. 21) at para. 1

⁵⁴Ibid at para. 22

Page: 14

It follows that the scope any duty of care that might exist between the Crown and

those who received the Vitek Proplast implants cannot, in my opinion, extend to a

person who did not receive them.⁵⁵

[48] Understood in this way, membership in the class is narrowly defined: implants made by a

particular manufacturer, utilizing a proprietary product in its manufacture (Proplast), implanted

without the requisite acceptance by the regulator (the granting of a Notice of Compliance), where

the recipient or his caregivers were misled into believing a Notice of Compliance had been

granted when they had not been, or, in circumstances where the Notice of Compliance, though

issued, should not have been.

[49] All of this when the suggestion is that there were few of these implants used in Canada.

There have been doubts about the numbers since the beginning. The following paragraph appears

in the reasons responding to the first certification hearing, the one that took place during June

2007 with the decision being released on September 5, 2007:

Plaintiff's counsel estimated the size of the class to be approximately 2600

individuals. The evidence in support of a number this large is not persuasive. The

estimate is based on information from Health Canada that 26,000 Vitek TMJ

implants were distributed in the United States and an assumption that, based

simply on the relative populations of Canada and the United States, "it would not

be unreasonable" to conclude that 2,600 units were implanted in Canada. The

information from Health Canada on which counsel relied only in part suggests

that the class might not exceed 200 persons.⁵⁶

[50] To the Court of Appeal, at the hearing of the special case, the assumption was that the

group was small:

In my view, it is arguable that the misrepresentations, combined with the failure

to correct that misrepresentation in the face of knowledge of the serious and

ongoing risk posed to a clearly definable and relatively small group of consumers,

could be viewed as akin to the regulator's failure in Fullowka to act in the face of

the known and ongoing dangers posed to the small and well-defined group of

miners who worked in the specific mine which the regulator knew to be unsafe.⁵⁷

[51] This perception is fundamental to the ultimate determination made by that Court. The

finding that it was not plain and obvious that the action could not succeed was based on the

understanding that the interaction that was the foundation of the required proximity was to other

than those affected by the regulator’s regular work, by definition a smaller group. Inspite of all of

this, as late as November 27, 2018, a motion was brought before Master McGraw who, while

acknowledging that some members would have died, understood the size of the class to have

⁵⁵Ibid at para. 25

⁵⁶Taylor v. Canada (Health), supra (fn. 17) at para. 60

⁵⁷Taylor v. Canada (Attorney General), supra (fn. 35) at para. 111

Page: 15

“approximately 2500 -2600 members”.⁵⁸The Submissions of the Plaintiff made at the end of the

trial use the same estimate.⁵⁹

[52] As will become apparent later in these reasons, there is some reason to wonder whether

any of the individuals who testified are, in fact, members of the supposed class. This leaves open

the prospect that there is no class.

[53] There are serious limitations to the impact of any decision the Court may render. There is

only a narrow route to the necessary proximity; it is only the alleged negligence of the Crown

that is at issue, its proportionate share of liability, if any, cannot be determined as a common

issue and the size of the class cannot be determined but could be small.

[54] In this consideration of the history, I move on to production. This was an issue of

controversy throughout the twenty years leading to this trial which continued, despite the efforts

of the Court to bring it to an end, up to and including the last days of the trial. It does not reflect

well on the parties, either of them. To my mind, it contributed substantially to the delay in

bringing this matter to resolution.

[55] On October 17, 2003, Master MacLeod released reasons in a motion dealing with

production.⁶⁰Viewed from the perspective of the time (the beginning of the process) it was both

comprehensive and prescient. It concerned the fundamental obligations of the Crown:

(1) Was it obliged to swear an affidavit of documents in the usual form?

(2) What was the range of documents to be produced?⁶¹

(3) Given the volume of documents to be produced and the production of copies on

CD ROM, what special rules should apply?⁶²

⁵⁸Taylor v. Attorney General of Canada, 2018 ONSC 7235 (CanLII) at para. 7

⁵⁹Submissions of the Plaintiff at para. 3

⁶⁰Logan v. Harper, 2003 CanLII 15592 (ON SC),

⁶¹Ibid at para. 3(b):

i)

type of TMJ implant apparently used in the plaintiff’s jaw?

ii) For the purpose of these cases, what are “documents” and is it necessary to disclose file

Are all documents relating to TMJ implants relevant or only those relating to the specific

folders, file folder tracking information and other documents disclosing who had possession of

or access to particular files at specific times?

iii)

is there only an obligation to disclose relevant documents retrieved from files?

iv) What is the extent of the obligation to provide a complete and comprehensive Schedule

Are files in their original form and order “documents” within the meaning of the rules or

C to the affidavit or list of documents?

⁶²Ibid at para. 3(c) a list was provided, as follows:

i)

Should the defendant be required to share its software for searching the CD ROM

version of the documents?

Page: 16

(4) Should Health Canada disclose how the search for documents was conducted,

who conducted it and what search criteria were used?

[56] In answering the questions that were put to him, the Master made an observation pointing

to the problem the parties faced:

A large document case, requires a specific plan for organized access to the

documents. Tracking document locations and permitting inspection of originals is

particularly problematic if the documents or files are required for the day to day

operations of an organization or if they may be subject to production in more than

one proceeding and may be required in the future. In such situations, the

immediate production obligation must be balanced against the need to maintain

the ongoing viability of the filing system. Production obligations can be onerous

and disruptive to an organization and some balance must be struck.⁶³

[57] He made plain the risk and advised as to the solution:

Finally, to avoid complete chaos on both sides, the organization and production of

the documents for the purpose of the litigation should ideally utilize a jointly

accepted plan of organization, authentication, identification and retrieval. What is

necessary therefore is definition of the scope of production, a production

procedure that is understood and accepted and liberal doses of procedural

collaboration and common sense. In these actions, I invite counsel to agree on the

plan but if agreement cannot be achieved, court management and supervision of

the production and discovery process appears necessary.⁶⁴

[58] The Master understood that, in this situation, there were practical limits to the process:

The plaintiffs wish paper copies of every document and wish to inspect every

original document. As I understand it they also wish to see every document in its

original file folder in original order and they wish production of the file tracking

documents or stamps which are believed to show who within Health Canada had

possession of any file and at what time. In the particular circumstances of this

case with the volume of documentation involved, that demand is unrealistic,

onerous, expensive and excessive. It is unnecessary for every document to be

subjected to this level of scrutiny. There is a right to inspect original documents

ii)

Notwithstanding the production of scanned, indexed and potentially text searchable

versions of the documents, is the plaintiff entitled to insist upon inspection of every original

document?

iii)

Must Health Canada provide paper copies of the documents in addition to the CD ROM

versions?

⁶³Ibid at para. 27

⁶⁴Ibid at para. 27

Page: 17

and there may be relevance to file tracking information or file organization but it

is necessary for such rights to be exercised in a focussed and targeted manner.⁶⁵

[59] All of which speaks to the clear-headed observation that some cooperation and

understanding needed to be applied to the difficulties of this particular document search.

[60] Fifteen years later, on October 29, 2018, a motion was brought before Master McGraw.

The motion was, in part, for an order striking out the Statement of Defence for “…the alleged

failure to produce documents pursuant to court orders, specifically the order of Master MacLeod

(as he then was) dated October 17, 2003”.⁶⁶This was taken in the face of a trial date that had

been set by Mr. Justice Firestone, a year earlier, on October 31, 2017. The Master was aware of

the problematic nature of this request. He wondered if some other remedy, one that would allow

the action to continue to trial, had been considered. He was advised that a proposal had been

made by the Plaintiff and rejected by the Crown. The motion began. Counsel for the Plaintiff, at

the conclusion of his submissions (approximately three hours into the motion) changed his

position. He advised the Court that rather than the striking of the defence, the Plaintiff was

seeking an order requiring further production including examination of a non-party, a former

employee of Health and Welfare Canada. The Crown was unable to respond. It had prepared to

answer what the Master referred to as the Plaintiff’s “aggressive and exclusive pursuit of

dismissal of the Defence”.⁶⁷The Master was confronted with a problem. As he saw it, even if the

Court was to make the order on that day, it was not practical to expect that it could be complied

with by the trial date that had been set, January 14, 2019:

Given the age and volume of the documents sought, some of them over 30 years

old and others which may no longer exist or are in dated electronic format that

must be located and searched, I am not satisfied that all steps contemplated by the

Proposed Order can even be completed in time for trial, let alone in time for any

documents produced or examination transcripts to be used as evidence at trial.

Further, if the Defendant wishes to oppose certain terms of the Proposed Order, it

is entitled to additional time to properly respond to the Plaintiff’s change of

position and the late filed materials. All of this must be balanced with the

Plaintiff’s entitlement to relevant documents prior to trial, particularly in a

procedurally and substantively complex matter such as this.

[61] It seems there was the risk of a further motion seeking a further examination:

Further, there is still the possibility that the Defendant will be bringing a motion

to examine Dr. Blais…⁶⁸

⁶⁵Ibid at para. 28

⁶⁶Taylor v. Attorney General of Canada, 2018 ONSC 6808 (CanLII) at para. 1

⁶⁷Ibid at para. 7

⁶⁸Ibid at para. 8

Page: 18

[62] The Master, relying on rules 37.02(2)(b) and 1.04 adjourned the motion sine die (without

a day), and returned the matter to Mr. Justice Firestone for directions with respect to the fixed

trial date, the motion and the changed relief being sought by the plaintiff.

[63] Justice Firestone issued a procedural order on November 5, 2018. A new trial date was

set, April 1, 2019, peremptory to all. The parties were ordered to attend before Master McGraw,

on November 27, 2018 and November 29, 2018, for the return of the motion. To ensure there

were no further delays, Mr. Justice Firestone added as a term of his order that there were to be no

further motions prior to trial other than those that might be heard by the trial judge.

[64] The motion was brought back before the Master who released his reasons on December

3, 2018. There were no fewer than ten motions (eight by the plaintiff, two by the Crown), all

dealing with production and requests for further examinations.⁶⁹The situation confronting the

Master was complicated by the history and the circumstances:

⁶⁹Ibid at para. 1:

i.)

the Plaintiff’s motion to compel the AGC to locate and produce copies of all versions of the report

prepared on May 28, 1981 by Dr. Pierre Blais, the Plaintiff’s key witness and a former research scientist in

Health Canada’s (“HC”) Medical Devices Bureau from 1976 until 1989, entitled “Plastic Fluid Handling

Systems and Implanted Devices: Rationale for regulatory amendments” (the “1981 Report”) together with

audit trails and search parameters as evidence of such efforts;

ii.)

the Plaintiff’s motion to compel the AGC to locate and produce electronic versions of all

documents for which the AGC disputes authenticity;

iii.)

the Plaintiff’s motion to compel the AGC to locate and produce publication and/or presentation

approval sheets for all papers prepared by Dr. Blais together with the underlying documents submitted in

support of such approval requests;

iv.)

v.)

the Plaintiff’s motion to compel the AGC to produce Dr. Blais’ personnel file;

the AGC’s motion to compel the production of Dr. Blais’ original documents for forensic

examination;

vi.)

the AGC’s motion to compel answers to undertakings and refusals arising from the examination of

Dr. Blais on September 26, 2018;

vii.)

the Plaintiff’s motion for the continued examination for discovery of Dr. William Freedland on

refusals from his discovery and questions properly arising therefrom, or, in the alternative, an order that Dr.

Freedland be examined pursuant to Rule 31.10;

viii.)

the Plaintiff’s motion to take the evidence of Dr. Napke, Dr. Neville, Dr. Blais and Kathryn Taylor

before trial pursuant to Rule 36.01;

ix.)

x.)

the AGC’s motion for the examination of Dr. Blais pursuant to Rule 31.10; and

the AGC’s motion to take the evidence of Francine Jacques and Dr. Noel Rose prior to trial

pursuant to Rule 36.01.

Page: 19

These 10 motions proceed in less than ideal circumstances. This is a 19-year,

procedurally and substantively complex class proceeding where the parties have

been engaged in ongoing production disputes for over 15 years. The documents

produced and sought are voluminous with many of them over 30 years old and

some even over 40. Some documents may no longer exist, previous searches may

not have located them and the potential places to search for documents is

overwhelming. Combined with the fixed peremptory trial date of April 1, 2019,

this strikes at the heart of proportionality and requires a balancing of the parties’

entitlement to know the case they must meet through the production of relevant

documents and right to oral discovery prior to trial and the efforts and costs

imposed on the other party. Quite simply, there is not enough time until trial to

complete the additional, comprehensive procedural steps which the parties seek

and which would be ideal for a case of this nature in the current circumstances.⁷⁰

[65] Master McGraw recognized that there had been delay, that both parties were at fault:

With the volume of available and searchable documents and a trial commencing

in 4 months, it is not possible to reconcile all of the parties’ positions and

allegations with respect to the Production Motions. They have not been resolved

over the last 15-plus years and there is no time to resolve them now. Both parties

must bear responsibility for the delayed, late and inadequate productions over the

last two decades and no purpose would be served in determining who is more to

blame at this time. This includes issues arising from the AGC’s alleged and/or

apparent non-compliance with the 2003 Order and Master Haberman’s directions

and the Plaintiff’s late delivery of documents in the possession of her key witness

19 years into the proceedings and 21 years after his involvement with related

actions. It is also inevitable that the de-certification, appeal and related pleadings

amendments have also contributed to the delays and complexity of these

proceedings. In my view, any allegations regarding the sufficiency, timing and

propriety or production are more appropriately issues for costs, either on these

motions or at trial, together with whatever conclusions or inferences the trial

Judge may draw generally. Allegations of spoliation are more appropriately an

issue for the trial Judge in any event (Muskoka Fuels v. Hassan Steel Fabricators

Ltd., [2009] O.J. No. 4782 (S.C.J.) at paras. 5-7).⁷¹

[66] Master McGraw considered each of the ten motions. The decisions he made ordered

some targeted searches and some specific searches; some to be done electronically, with the

provision of a description in each case of the Crown’s best efforts including where it searched,

the search terms; and at least one physical search (material associated with Pierre Blais). Orders

were made requiring two witnesses (Pierre Blais and Francine Jacques (Gaudette)) to be

examined, one in Toronto and the other in Montreal, and for the Plaintiff to submit

interrogatories to be answered by various of the Crown’s employees (Dr. Freedland, Dr. David

⁷⁰Taylor v. Attorney General of Canada, supra (fn. 58) at para. 5

⁷¹Ibid at para. 21

Page: 20

Taylor and Lindsay Blaney). Time limits were imposed: 45 days for some of the items ordered,

by February 28, 2019 for others and 60 days for the interrogatories.

[67] What is clear is the intention of both Mr. Justice Firestone and Master McGraw that this

would be the end of what had been an ongoing dispute concerning production. It was not. On

March 19 and 20, 2019, less than two weeks before the trial was to begin, the Crown produced a

book of fresh documents. Counsel for Plaintiff submitted he had been asking for some of them

over an extended period of time. Not surprisingly, the Plaintiff complained. This required an

appearance on March 22, 2019. Counsel for the Plaintiff cited the long history of attempts to get

complete production from the Crown. Counsel asked for an adjournment. Counsel for the Crown

acknowledged that some of the documents should have been produced earlier but also suggested

that the Plaintiff was already aware of some of those that were the subject of this late production.

The adjournment was refused. A series of directions were provided to overcome the difficulties

the situation presented. Among them, that of the documents that were the subject of the motion,

the only ones that could be produced at trial were those the Plaintiff agreed to or those the

Plaintiff indicated an intention to rely on.

[68] There was a further and subsequent complaint. During March 2018 the Plaintiff produced

some documents from Dr. Pierre Blais. He had had the documents for at least 30 years. The

Crown had indicated an intention to question the authenticity of certain of those documents. This

was among the ten motions heard by Master McGraw and considered by him in his reasons of

December 3, 2018. Expert reports were referred to. The Plaintiff did not have them. This

spawned another request for an adjournment by the Plaintiff. The adjournment was refused but

the issue delayed to be dealt with after all the other evidence was completed, if the Crown

remained intent on raising the issue.

[69] As late as September 13, 2019, the Friday before the trial was to resume following a ten

week break, with only one defence witness remaining to be called, counsel for the Plaintiff wrote

to the Court seeking a motion for directions for, among other things, production and

examinations surrounding the issue of the authenticity of the impugned documents of Pierre

Blais. Counsel for the Crown responded by letter, the same day, sparking a response, in turn,

from counsel for the Plaintiff which included the following paragraph:

Mr. Gaudet’s letter revives the Plaintiff’s concerns about the AGC’s continuing

non-compliance with prior production Orders. This noncompliance vitiates the

Plaintiff’s ability to advance her case. Relevant documents were and continue to

be withheld from production and discovery. Trial fairness cannot be restored

without focussed remedial relief and sanction.

[70] I have reviewed the letter from Mr. Gaudet. I am hard pressed to understand how it would

be a catalyst for going back to Master MacLeod’s order of October 17, 2003. It does not matter.

What this exchange demonstrates is that to the very end, 16 years after the order of Master

MacLeod, the parties continued to battle over productions. Like Master McGraw I see no

purpose in trying to assess blame. I say only that it is clear that the injunction of Master

MacLeod, that cooperation was required, was not adhered to. This was to the detriment of the

parties and to the proceeding.

Page: 21

THE COMMON ISSUES

[71] Out of the history of this proceeding and its certification was the identification of the

common issues to be dealt with in this trial. They are:

(1) Did Canada owe a duty of care to class members?

(2) If so, did Canada breach the applicable standard of care?

(3) If so, can Vitek Proplast temporomandibular joint implants cause injury to those

receiving them?

THE REGULATORY REGIME

[72] The Food and Drugs Act was passed in 1920. Statutory provisions specifically dealing

with medical devices were first enacted on May 14, 1953 and came into force on August 16,

1954.⁷²The Food and Drugs Act was introduced at the material time, as it is now, as “An Act

respecting food, drugs cosmetics and therapeutic devices”.⁷³What is a “medical device”? The

Food and Drugs Act did defined the term “device”:

“device” means any article, instrument, apparatus or contrivance, including any

component, part or accessory thereof, manufactured, sold or represented for use in

(a) the diagnosis, treatment, migration or prevention of a disease,

disorder or abnormal physical state, or the symptoms thereof, in

man or animal,

(b) restoring, correcting or modifying a body function or the body

structure of a man or animal,

(c) the diagnosis of pregnancy in humans or animals, or

(d) the care of humans or animals during pregnancy and at and

after birth of the offspring, including care of the offspring,

and includes a contraceptive device but does not include a drug.⁷⁴

[Emphasis added]

[73] For the purposes of these reasons, we are concerned with subparagraph (b).

Temporomandibular joint implants replace the meniscus that separates two elements of the jaw,

the fossa and the condyle, to allow for its proper movement.⁷⁵

⁷²Agreed Statement of Facts at para. 13

⁷³R.S.C. 1985 c. F. 279 (The definition has since been amended)

⁷⁴R.S.C. 1985 c. F. 27 at s. 2

Page: 22

[74] Beginning in December 1954 and through August 1975 “devices” were also subject to

the provisions of the Food and Drug Regulations. The concern for and interest in the regulation

of medical devices galvanized in and around 1975. This was occasioned by two unfortunate

examples: the Dalkon Shield, an intrauterine contraceptive device, and the nuclear batteries

utilized in pacemakers inserted into the heart. The former caused infection; the latter

disintegrated in the body. A third factor was the “beginning of intraocular surgery”.⁷⁶As a result,

on September 2, 1975, the Medical Devices Regulations, a regulation specific to these devices,

was introduced.⁷⁷Among other things, the Medical Devices Regulations govern the entry of

devices into the market in Canada. From the outset, the Medical Devices Regulations prohibited

the importation into Canada of any device the sale of which would violate any part of the Food

and Drugs Act or the Medical Devices Regulations.⁷⁸On March 25, 1977, a limited form of pre-

market review was introduced into the Medical Devices Regulations.⁷⁹It was restricted to “new

devices”. “New devices” were, and remain in the current version of the regulations, defined as:

“new device”, in relation to a manufacturer, means a device listed in the table to

this Part that

(a) has not been sold previously in Canada by that manufacturer,

(b) it is, in respect of any characteristic, different from any device

sold previously in Canada by that manufacturer, or

(c) is, in respect of all characteristics, identical with a device sold

previously in Canada by that manufacturer that has previously

been recalled or withdrawn from the market or that he has ceased

to manufacture or sell.⁸⁰

[Emphasis added]

[75] As of the promulgation of the Medical Devices Regulations on March 25, 1977, the

“device[s] listed in the table to this Part” included only: (1) Intra-uterine devices and (2) Cardiac

⁷⁵The Agreed Statement of Facts at para. 42 describes the temporomandibular joint as follows:

The TMJ is comprised of the condylar head of the mandible, the glenoid fossa of the temporal

bone and an interposed articular disc. Additionally, these structures are supported by a joint

capsule and ligaments and are connected to the muscles of mastication.

⁷⁶Transcript of Pierre Blais (April 26, 2019) at pp. 49-51

⁷⁷Consolidated Regulations of Canada (1978) Volume VIII, Ch 871

⁷⁸SOR/75-526 at s. 15 and Consolidated Regulations of Canada (1978) Volume VIII, Ch 871 at s. 16:

Subject to section 19 [subsequently s. 20], no person shall import into Canada for sale a device

the sale of which in Canada constitute a violation of the Act or these Regulations.

⁷⁹Agreed Statement of Facts at para 18 referring to Medical Devices Regulations, amendment SOR/77-258,

Schedule II, s.28

⁸⁰SOR/77-258 at s. 28 (in the current consolidated regulation s. 32)

Page: 23

pacemakers. A manufacturer of a “new device” was prohibited from selling or advertising that

device unless the manufacturer received a Notice of Compliance from Health and Welfare

Canada. To obtain a Notice of Compliance, the manufacturer was required to submit to Health

and Welfare Canada evidence establishing the safety and efficacy of the new device. On October

8, 1982, the Table to Part V of the Medical Devices Regulations was amended to extend the pre-

market review to any “new device” designed to be implanted into the tissues or body cavities of

a person for 30 days or more.⁸¹This amendment became effective on April 1, 1983. From this, it

is apparent, and it was not disputed, that what in 1977 was Part IV of the Medical Devices

Regulations and is now Part V applied to the Vitek Proplast Implants that are at the centre of this

proceeding. To be clear it was understood and accepted by all parties that in order to be

mandated for sale in Canada these products required Notices of Compliance. It should be said

that a Notice of Compliance allows the product involved to be sold and used in Canada.

However, it signifies only that the submissions made in support of the application “complied”

with the legislative requirements. A Notice of Compliance is not a statement by the government

that the product is safe, only that the work required to justify its entry into the Canadian market

according to the tests set out in the Medical Devices Regulations has been completed. In short, a

Notice of Compliance is not a guarantee, by the government, that the device is safe for use and

will assist in reducing pain or benefit the problem being treated. The review it conducts is as to

the sufficiency of the work; it is not a peer review as to how it was conducted or a replication

that confirms the results. The legislation makes clear that the responsibility to conduct proper

studies lies with the manufacturer.

[76] At the time the submissions seeking Notices of Compliance for the products of interest to

this case were made there was some suggestion, by those applying, that the product had been

“sold previously in Canada” and that they should be “grandfathered” and not treated as “new

devices”. Documents that purported to confirm those sales were not accepted as such by the

representatives of Health and Welfare Canada. As the Plaintiff has asserted, and as the Defendant

has readily conceded, they had to be treated as they were, that is, as new devices to which the

requirements of Part V of the Medical Devices Regulations applied.

⁸¹Agreed Statement of Facts at para. 21 and Consolidated Regulations of Canada (1978) Volume VIII, Ch 871 and

Medical Devices Regulations, amendment SOR/82-914:

SCHEDULE

The table to Part V of the Medical Devices Regulations is revoked and the following substituted

therefore:

…

3. Any device designated to be implanted into the tissues or body cavities of a person for 30 days

or more.

Page: 24

[77] There were criteria applicable to the content and assessment of the submissions made to

support the request for any Notices of Compliance for “new devices”. Under the heading:

“Submission” the Regulation noted:

s. 35(1) For the purpose of obtaining a notice of compliance, the manufacturer of

a new device shall submit to the Director

(a)

evidence of the safety of the device consisting of at least

(i)

the name and mark under which the devices to be sold,

the purpose of the device and its method of use,

the performance characteristics of the device,

(ii)

(iii)

(iv)

the specifications and limits set for those materials of the

device that may come in contact with body tissues or fluids and a

summary of the test methods used to ensure conformity with those

specifications and limits,

(v)

if sold as sterile, the method of sterilization and the

recommended method of resterilization, if applicable,

(vi)

a general description of the plant, equipment and

procedures used in the manufacture of the device,

(vii) the quality control program and procedures used ensuring

manufacturing, packaging and sterilization of the device, and

(viii) that full data of all chemical studies, analysis and animal

studies carried out to determine the bio-compatibility of those

materials of the device that may, in the normal use, come in

contact with body tissues or fluids;

(b)

evidence of the effectiveness of the device, consisting of at least

(i)

the results of all clinical trials to show the effectiveness of

the device,

(ii)

where clinical trials have not been made, the results of

animal studies or appropriate tests that demonstrate a probability of

effectiveness in humans, and

(iii) all known adverse reactions or contra-indications to the use

of the device under the recommended conditions; and

Page: 25

(c)

drafts of all labels, package inserts, product brochures and file

cards to be used in connection with the device.

(2) Where the Director is of the opinion that the evidence and materials submitted

by a manufacturer pursuant to subsection (1) are not sufficient for him to

determine whether or not he should issue a notice of compliance for the purpose

of selling or advertising the new device, the Director may require the

manufacturer to submit to him further information concerning the device or any

samples of any of the ingredients or components of the device and of the device

itself.

[78] Under the heading: “Issue of Notice of Compliance”:

s. 36. Within sixty days after the latest date of the receipt by the Director of

evidence, materials or information submitted by a manufacturer under section 35,

(a)

where that Director is satisfied that the manufacturer has provided

substantial evidence that

(i)

the conditions of production and quality control are suitable for

controlling the quality, stability, safety and performance of the new

device,

(ii)

the new device can be used for the purpose and under the

conditions of use recommended by the manufacturer without undue risk to

humans,

(iii) the new device is clinically effective for the purpose and under the

conditions of use recommended by the manufacturer or that sufficient animal

studies have been carried out to establish a probability of effectiveness in humans,

and

(iv)

the drafts of all labels, package inserts, product brochures and file

cards to be used in connection with the device are adequate,

the Director shall issue to the manufacturer a notice of compliance; or

(b)

where that Director is not satisfied that the manufacturer has provided the

evidence referred to in paragraph (a), the Director shall refuse to issue a notice of

compliance and shall notify the manufacturer of his refusal and of the reasons

therefore.⁸²

⁸²SOR/77-258 s.31 and s. 32 (in the current consolidated regulation s. 35 and s. 36)

Page: 26

[79] Accordingly, the regulation, in the form applicable when the requests for Notices of

Compliance were made, first in 1987 and again in 1988, continued to require a demonstration of

both “safety” and “efficacy”. As was acknowledged by at least two witnesses called by the

Plaintiff⁸³, these two requirements do not stand as independent standards to be treated and

considered separate and apart, one from the other. They are not absolute tests measurable on a bi-

lateral basis: either safe or not safe; either effective or not effective. Instead they function as two

ends of a spectrum: at one end devices which are safe but do nothing to alleviate the illness or

disfunction which requires treatment, and at the other end, devices which may cure the concern

but at the price of some other undeniable harm. Obviously, neither of these two extremes would

generate the issuance of a Notice of Compliance. The determination of whether to issue a Notice

of Compliance is a consideration of where, on the continuum between these two extremes, taking

into account the degree and likelihood of relief measured against the risk of further harm, the

predicted functioning of the device may fall and whether on that basis it is appropriate to issue a

Notice of Compliance:

Q. And we hear the terms evidence of safety and efficacy throughout the last

month. Can you give us your overview of what that means?

A. Safety and efficacy are the two essential attributes that are demanded of a

medical device, offered up matter of drug as well. It is a quantity that is measured

against the importance of the need that it fulfills. For example, a product can be

highly efficacious and very safe, but totally useless medically. Conversely a

product can be extremely dangerous and would have a strong possibility of being

an inefficacious but is essential surgically. The balance between the two is the

area that we are now discussing.⁸⁴

[80] What this demonstrates is that there is no, and can be no, certain or definitive answer. It is

a balancing and, thus, inherently contains a high degree of discretion and consideration specific

to the individual case.

[81] The limitation imposed by the regulation sets the context in which the choice is to be

made. There is a time limit. The decision is to be taken within 60 days. This is not much time to

consider the kind of detailed studies new approaches to science and treatment, by their nature,

require. Hence the proposition that the determination to be made is not as to the rectitude of the

studies but as to whether they comply with the regulations that govern these submissions.

[82] The evidence shown by the studies was required to be “substantial”: first in showing

“safety” measured as use “without…undue risk” and second, either clinical efficacy (efficacy

demonstrated through trials on humans) that shows the device to be effective under the

conditions of use recommended by the manufacturer or efficacy shown through animal studies

that establish a probability of effectiveness in humans.

⁸³Transcript of Pierre Blais (April 26, 2019) at pp. 71-73 and Transcript of Richard Lawuyi (May 27, 2019) at

pp.43-46

⁸⁴Ibid (Pierre Blais) at p. 71

Page: 27

[83] The answer as to whether a Notice of Compliance should be issued is to be arrived at

within the time frame set and consistent with the standards to be met. Finding the balance

between “safety” and “efficacy” reflects on the two competing policy values at the core of the

regulatory scheme. On the one hand, our desire to have those in the industry find, develop and

produce devices that will assist those who are suffering and on the other to avoid causing more

harm. Later in these reasons I will be referring to “Cotrel rods” which were, and may still be,

implanted in some, particularly teenagers, to assist in remedying curvature of the spine. Surgeons

complained because these devices could not be sold and used because the necessary Notices of

Compliance had not yet been issued. They wanted to help their patients. They had to wait for the

issuance of a Notice of Compliance that was first refused pending the delivery of more

information and later granted. On the other hand, it is generally known (I believe I can take

judicial notice) that Dalkon Shields which were made available for sale were not sufficiently

tested and caused considerable damage. The policy formulation is directed to avoiding both these

results but inevitably will not always succeed. Heather Sheardown is a Professor in the

Department of Chemical Engineering at McMaster University. I will say more about her

qualifications later in these reasons. For the moment I only point out an example she provided

where despite the best intentions, the balance failed. A cornea transplant was approved by the

Federal Drug Administration in the United States in 2001. It was received by thousands of

patients. By 2007 the failure rate of 50% became widely known. Some patients went blind.

Heather Sheardown noted that in many cases we simply do not know what the long-term impacts

of these new medical devices will be.⁸⁵Nirmala Chopra, who was for a time, in charge of the

premarket review of medical devices, advised the court that there was an expectation that some

new devices would cause some difficulty and that generally they would be identified within the

first five years of any new device entering the market.

PROPLAST

[84] Proplast is a trademark that is used to describe a family of composite materials that were

designed, manufactured and sold by Vitek Inc., a Houston-based company founded by Dr.

Charles Homsy in 1969.⁸⁶Proplast is composed of a fluorocarbon polymer matrix and a

reinforcing material, such as fibre or powder. The fluorocarbon polymer matrix includes

Polytetrafluoroethylene (“PTFE” commonly referred to as Teflon) and may include Fluorinated

Ethylene Propylene (“FEP”) polymers and/or fluorocarbon polymer fibres. The reinforcing fibres

or powder may be an organic or inorganic material, including carbon fibre, aluminum oxide or

hydroxyapatite. The added fibres or powder are intended to provide enhanced mechanical

strength while the fluoropolymer is intended to provide a chemically inert, continuous host

material, or polymer matrix.⁸⁷

[85] Proplast has been produced in at least three standard types: Proplast I (PTFE/carbon

competent material), Proplast II (PTFE/aluminum oxide competent material) and Proplast HA

⁸⁵Transcript of Heather Sheardown (May 30, 2019) at pp. 45-46

⁸⁶Agreed Statement of Facts at para. 43

⁸⁷Agreed Statement of Facts at para. 44 referring to Exhibit 8: Expert Report of Dr. Christopher K. Ober, August

24, 2018

Page: 28

(PTFE/hydroxyapatite competent material).⁸⁸Proplast has been manufactured in a variety of

forms including films, sheets, blocks and coatings. In each case, Proplast may be different –

different composition, different manufacturing processes and different physical and chemical

properties.⁸⁹All types of Proplast have in common soft PTFE fluorocarbon polymer resin and

fibre that dominate their surface properties and form a porous matrix. The Proplast types are

distinguished by differences in the filler that lead to differences in mechanical and other physical

properties between the Proplast types.⁹⁰

[86] The Plaintiff does not agree that the various Proplast products are different. Relying on

the evidence of Elliot Wayne Tunis, a physician who had implanted Vitek Proplast

temporomandibular implants, the Submissions of the Plaintiff (the written submissions presented

on her behalf at the conclusion of the trial) note:

There was no difference between the Proplast IPIs and Proplast sheeting with

Teflon laminated to it, other than that the IPIs were manufactured from these

sheets by cutting the sheet into an anatomic size.⁹¹

[87] What is important is that for the purpose of regulating the devices in issue, those

responsible for premarket review of the many Proplast products saw differences. As we shall see,

the complaint made at the time the first applications for Notices of Compliance were received

was that they had been lumped together such that it was not possible to attribute the supporting

data to the specific devices to which it applied. The applications were refused. When a second

attempt was made, the same concern arose. Eventually the regulator (not the applicant) organized

the devices into eight groups, presumably to assist Vitek Inc. Even so, as will become apparent,

the various Vitek Proplast products were treated differently. Some were issued Notices of

Compliance (Proplast Block and Sheeting); many were not (Proplast IPI’s).

[88] Proplast was used as a material component of temporomandibular joint implants

produced by Vitek Inc. and available to Instrumentarium Inc. to be distributed in Canada.

Proplast was intended to anchor the implant to the upper bone of the temporomandibular joint.

it’s porous nature and potential for tissue ingrowth were intended as a feature that would

encourage stability in the temporomandibular joint.⁹²Over time it became apparent that the

PTFE (Teflon) included as part of certain forms of Proplast could, after being implanted,

fragment, delaminate or otherwise be damaged. Debris in the joint from implants could

contribute to progressive bone degenerative change and giant cell reaction.⁹³In time there was a

product recall.

⁸⁸Exhibit 51 at T. 1 (Expert Report of Dr. Doran Ryan, July 28, 2018) at p. 21

⁸⁹Exhibit 8 (Expert Report of Dr. Christopher K. Ober, August 24, 2018) at p 5

⁹⁰Ibid at p. 6-7

⁹¹Submissions of the Plaintiff at para. 20 in turn footnoting Tunis Transcript page 66. (The evidence of Elliot

Wayne Tunis was in the form of a Cross-examination conducted in another proceeding. The basis for its acceptance

as evidence in this trial is reviewed at para. [178] herein.)

⁹²Agreed Statement of Facts at para. 48

⁹³Ibid at para. 114

Page: 29

WHAT WAS KNOWN ABOUT PROPLAST, BY WHOM AND WHEN WAS IT KNOWN

[89] Science does not tend to develop understanding in moments of immediate and complete

insight. Rather it evolves over time. Robert Pilliar testified at the trial. He is an engineer by

training but has worked, taught and studied in the area of medical devices for many years. When

he first appeared, he seemed to acknowledge this perspective but when called in Reply he

demurred. As he perceives it, evolution is a process generally applicable in biology. As he sees

it, science does not evolve so much as it moves through steps.⁹⁴For the purposes of these reasons

such a distinction does not matter. The point is that our understanding of science changes and

becomes more complete as our knowledge and experience increase. Nonetheless, movement “in

steps” suggests a linear progression (both forward and backward). Evolution in its current

understanding is a broader concept. Among its definitions:

A process of change in a certain direction…a process of continuous change from

a lower, simpler or worse to a higher, more complex or better state…a process of

gradual and relatively peaceful social, political and economic advance…a theory

that the various types of animals and plants have their origin in pre-existing types

and that the distinguishable differences are due to modifications in successive

generations… a process in which the whole universe is a progression of

interrelated phenomena⁹⁵

[90] Each of these meanings connotes continuous and gradual change that can occur in a

variety of circumstances. In this case, in the overall appreciation of the risks and harm associated

with Proplast, one of the issues raised was whether this potential should have been appreciated

sooner by Health and Welfare Canada such that entry into the market of any Proplast related

product, at least for use as temporomandibular joint implants, should never have taken place,

should have been recalled sooner and patients directly advised of the risks. To analyse this

proposition (and using what has become a too often used colloquialism) it is important to come

to an understanding of who knew what and when they knew it.

[91] The evidence addressing the question of the degree and timing of any understanding

concerning the usefulness of Proplast products began with Pierre Blais. He was a research

scientist employed by the Medical Devices Bureau (and its successors) from its inception until

his departure in 1989. In the context of this trial, he was a controversial figure. From the

perspective offered by the Plaintiff, Pierre Blais was central to the understanding, within Health

and Welfare Canada, of Proplast and its dangers. Attention was drawn to meetings and

conferences he said he attended, papers he wrote, a book he contributed to and warnings he said

he instilled in more senior officials at Health and Welfare Canada. With a closer look, the idea of

this pivotal role dissipates in the uncertainty and confusion that accompanied his participation in

the events he referred to and in the trial. He left his employment with Health and Welfare Canada

under difficult circumstances. He was terminated for an alleged failure to comply with internal

⁹⁴Transcript of Robert Pilliar (September 23, 2019) at p. 24-25

Page: 30

policy governing, among other things, release of information to the media.⁹⁶He grieved. The

grievance was settled. He was reinstated but retired a day later.⁹⁷He was called as a witness, not

by the Crown, but on behalf of the Plaintiff. He had been available to the Plaintiff’s counsel for

many years. Even so, in 2017, he produced documents that had not previously been seen.⁹⁸He

happened on them when going over files he maintained in his home. The authenticity of four of

these documents was questioned by the Crown. At a pretrial conference during the weeks leading

up to the commencement of the trial, counsel for the Plaintiff advised they were unprepared to

deal with the issue. One of the reports on which the Crown sought to rely had not been delivered.

The Plaintiff required time to retain an expert, prepare a response. This resulted in one of the

adjournment requests to which I have already referred. This was refused. The issue was set aside.

The documents in issue were to be admitted without reference to their authenticity. That issue, if

the Crown still intended to proceed with it, would be heard in a separate proceeding at the end of

the evidence but before final submissions were made. Although not without difficulty, as the end

of the evidence approached, that is what happened.

[92] I will refer to each of the four documents as they become relevant. This is provided at the

outset of these reasons in response to a proposition put in the “Submissions of the Plaintiff”. It is

said there that the allegations made against Pierre Blais should be rejected. This is not surprising

but it is not all that was submitted. Counsel for the Plaintiff goes on:

But in the aftermath of those findings, the Plaintiff submits that Dr. Blais’

evidence must be accepted as true. Indeed the AGC resiled from its decision to

call Health Canada witnesses who would have been in positions to refute Dr.

Blais’ evidence.⁹⁹

[93] In other words, as counsel sees it, if the four documents are found to be authentic, there

need be no further inquiry into the reliability of what those documents say, or it would seem, the

value of any of the other evidence provided by Pierre Blais. To my mind, this is wrong in a

profound way. If the documents are authentic, their reliability, probative value and impact in

contrast to what others have said would remain open for the Court to examine. I go further. It

would be a failure of the Court, in carrying out its responsibilities, if it did not do so. If the

Crown had other relevant evidence that it could have called and chose not to do so, that is a risk

it took.

[94] For all of his experience, the Plaintiff did not seek to qualify Pierre Blais as an expert. In

the Submissions of the Plaintiff, Pierre Blais is referred to as a “non-party, lay witness”. He is

not a party but I am uncertain as to the implication of his being a “lay witness”. It is undeniable

that he was employed through the material time, by Health and Welfare Canada, at the Medical

Devices Bureau, through whatever name changes and restructuring that occurred during that

⁹⁶Exhibit 34 at T. 11 (Letter dated July 14, 1989 Dr. A. J. Liston to Pierre Blais.)

⁹⁷Ibid at T. 12 (Settlement Offer)

⁹⁸Transcript of Pierre Blais (May 10, 2019) at p. 425-428 and 442-443

⁹⁹Submissions of the Plaintiff at para. 152

Page: 31

period. The meaningful distinction, at least as I understand it, is as a “fact” as opposed to an

“expert” witness. I take this to be the import of the Submissions of the Plaintiff where the

following is said:

The Plaintiff called Dr. Blais as a lay witness because of his first-hand knowledge

that Health Canada’s middle and senior management knew that Proplast was

unsafe from the early 1980’s onward.¹⁰⁰

[95] I mention this because much of the evidence of Pierre Blais dealt with the state of

knowledge concerning Proplast as time progressed. What may be interpreted as fact today may

not have been understood as such at an earlier time. As will become apparent as these reasons

proceed, what the Plaintiff, relying on Pierre Blais, believes should have been understood early

in the progress of these events is not so certain. This is especially so when the evidence of Pierre

Blais is fully examined and considered in the context of what was said by others. At the time,

perhaps still, there are experts who do not agree with what the Plaintiff takes to be fact. Some of

this is better understood, at least at the times in question, as opinions. Nonetheless, so far as I can

recall (there were 55 days of evidence) not once was the evidence given by Pierre Blais objected

to as crossing from fact to opinion. I take his evidence to be demonstrative of what he saw as fact

but which others may have seen differently. I believe this to be consistent with the evidence and

how it was provided but also sensitive to the understanding that broad scientific acceptance is not

generally a matter of immediate insight but the result of the sort of evolution that occurs over

time as experience increases knowledge.

[96] As explained by Pierre Blais, the Medical Devices Bureau was formed in 1975. It was a

consolidation of those parts of the Health Protection Branch that were concerned with non-drug

health care products. Pierre Blais recalled that he was the fifth employee brought into the new

Bureau.¹⁰¹The catalyst for this consolidation was the appearance of non-drug medical devices

(such as the Dalkon Shield, pacemaker batteries and the beginning of intraocular surgery), and

the need for the responsibility for their regulation to have a home. As depicted by Pierre Blais

this reorganization was not a well-planned response to the developing concerns. “It was

opportunistic in a sense. It was done piecemeal. And there was no precedent…”¹⁰²

[97] In summer of 1976, Pierre Blais attended a Gordon Conference.¹⁰³While the origins,

source and substance of “a Gordon Conference” was not reviewed, it seems that this was one of a

series of such conferences covering wide areas of scientific interest. Dr. Charles Homsy, the

person recognized as the developer of Proplast, made a presentation. It concerned Proplast and

its properties. Those in attendance were identified by Pierre Blais as “one half of the

¹⁰⁰Ibid at para. 148

¹⁰¹Transcript of Pierre Blais (April 26, 2019) at p. 47)

¹⁰²Ibid at p. 51

¹⁰³At first Pierre Blais recalled this conference as taking place during 1977. However, the program of the conference

says it was 1976 (Exhibit 34 v. 1 T. 15) as do the notes prepared, at the time, by Pierre Blais (Exhibit 34 v. 1 T. 16).

(p. 15) see also Transcript of Pierre Blais (May 10, 2019) at p. 483

Page: 32

contributors to the biomaterials of tissue and bone in the world”¹⁰⁴[Emphasis added]. He stated

his own immediate response:

I was very disappointed by the lecture, but other attendees had other views.¹⁰⁵

[98] He went on to describe the general reaction of those in attendance. It was more than

disappointment. It was outrage. As witnessed by Pierre Blais the scene was one of

“pandemonium.” Charles Homsy was besieged by questions from an audience angered by what

he was saying. As outlined by Pierre Blais, the expressed concerns included:

…why Doctor Homsy was promoting the use of a product where the components

were individual carcinogens or collective carcinogens, firstly. The second

concern was that they were complaining that the mere totality of his formula were

so irritating that they would produce an outright rejection reaction on simply

being there. A third concern was that the photographs and the photo micrographs

that Doctor Homsy had shown before showed the Proplast to be disintegrating and

they had not discussed this.

…

It was the overlying, the fact that the material did not have enough strength to

remain together and that the debris was being disseminated throughout the tissue

and the living organism through fluids, such as the lymphatic fluid were the key

concern to the whole thing and was the basis for why the audience was very

unfavorably inclined.¹⁰⁶

[99] This evidence was anecdotal. There is no data, analysis, report or reviewable assessment

of any potential risk on which a regulator could rely in examining the overall value of the

product. There are some handwritten notes made at the time by Pierre Blais. They include

negative comments with respect to another of the presenters (“PURE BULL” repeated 13 times)

but only technical observations insofar as what was said by Charles Homsy.¹⁰⁷Even so, those at

Health and Welfare Canada took account of what Pierre Blais described. Upon his return he

reviewed what had taken place with his immediate superior, Dr. Ronald Campbell and the

director of the Medical Devices Bureau, Dr. Ajit DasGupta. As Pierre Blais recalled, they met

with the personnel of the Bureau responsible for those devices treated by Part V of the Medical

Devices Regulations (“new devices”) as well as those responsible for the notification

requirements applicable to other medical devices.¹⁰⁸The investigation went beyond the Bureau

¹⁰⁴Transcript of Pierre Blais (April 26, 2019) at p. 123

¹⁰⁵Ibid at p. 122-123

¹⁰⁶Transcript of Pierre Blais (April 26, 2019) at p. 124-125

¹⁰⁷Exhibit 27 v. 3 at T’s A, B, C and D

¹⁰⁸To my mind there is some confusion in this, given that the amendments to the Medical Devices Regulations

which introduced the concept of “new devices” did not become effective until March 25, 1977. At the time it was

introduced, it was Part IV. In any case, the point is that at the time those responsible followed up on the information

brought back by Pierre Blais from the Gordon Conference of 1976.

Page: 33

through telephone calls with, and visits to, parties known to be reliable. A conclusion was

reached. The product was not being sold in Canada through any recognized means or distributor.

[100] In the period following the Gordon Conference, Pierre Blais says he continued to raise

concerns:

Q. Between 1977 and your ultimate final leaving of Health and Welfare Canada

at the end of 1989, were you engaged in any debate with any co-worker at Health

and Welfare Canada of any rank about the safety of Proplast?

A. Yes.

Q. With whom?

A. The mere totality of the early generation of evaluators and then later in formal

lectures that I would give to other members of the department who were not part

of the Bureau, specifically, the field operations group. I recollect, and I may even

have notes about a lecture that I delivered on frangible implants in connection

with the Montreal group, and in connection also with the Toronto field operations

group.¹⁰⁹

[Emphasis added]

[101] Pierre Blais told the Court that by 1981 there was a common view extant in Health and

Welfare Canada that the product was “damaging”:

Q. I’m asking if there was any debate within Health and Welfare Canada that

there was a safe use or an efficacious use for Proplast?

A. Such debates did take place, but only in the academic sense. There was

unanimity in the belief that the product was very much damaging from certainly

1981 onward, and that was general. It was not just one, one view, or even the

official view of our directorship, it spread to everybody...¹¹⁰

[Emphasis added]

[102] To suggest that there was no one at Health and Welfare Canada who wondered whether

the product had value is not accurate. Dr. John Orpin, Medical Advisor, Division of Clinical

Assessment, Bureau of Medical Devices¹¹¹voiced a caution that patients not be deprived of

something useful.¹¹²As put by Pierre Blais this was explained as follows:

¹⁰⁹Transcript of Pierre Blais (April 29, 2019) at pp. 11-12

¹¹⁰Ibid at p. 14

¹¹¹Exhibit 27 v. 3 at T. H (Letter January 17, 1985 (Dr. J.A. Orpin to Dr. M.T. Cooper)

¹¹²Transcript of Pierre Blais (April 29, 2019) at p. 108

Page: 34

John Orpin, who was also a colleague and a co-worker under Dr. Campbell, and

his comment was that – how did he put it – he said but what if perchance it has

some value. By declaring it unsuitable and unacceptable, could we be depriving a

patient of something that could be useful. But it was not a criticism. It was not

someone who supported Proplast. Quite on the contrary. He was simply

advocated that could we possibly have made mistake. It was the only exception.¹¹³

[103] The source of any information that contributed to this “unanimous belief” was Pierre

Blais. No additional work or research was referred to. There is no suggestion that over these

years any notification or application for a Notice of Compliance, along with the data that would

be required with such a submission, was received for any Proplast product, much less for use as a

temporomandibular joint implant. There is no suggestion that prior to 1981 there were any sales

or use of Proplast temporomandibular joint implants in Canada.¹¹⁴

[104] The evidence, taken as a whole, suggests that Pierre Blais did not play the role he has

defined for himself. Some of the employees at the Health Protection Branch had never met him,

others say he played no role they are aware of in respect of Proplast and others say his primary

interest was with the difficulties being encountered with breast implants. There were people who

disagreed with him. They were referred to by Pierre Blais as dissenters:¹¹⁵

¹¹³Ibid at p. 107

¹¹⁴At Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. 2 T. 84 and Exhibit 73 T. 4 at p. 14 there is reference to two

Proplast-like knee implants:

A Canadian Dow Corning representatives [sic]in Montréal recently disclaimed having ever sold

Proplast products. Reports of unregistered 'clearinghouse' distributors, mail order advertisements

and commercial irregularities involving Proplast and Vitek have been received. Two cases

involving implantation of Proplast-like material to the knee were uncovered in the Québec city

area incidentally to a study on knee surgery….

With respect to temporomandibular implants the same document notes, at the same page:

Adverse events surround the use of Vitek Proplast in the US and a controversy has broken out in

Louisiana dental surgery circles. The Canadian Dental Association was informed about the

matter. Complications emerge first in situations involving the temporo mandibular joint (TMJ)

repair. An investigational Vitek implant claimed to be suitable for insertion during a simple

office procedures is [sic] presently promoted for mild discomfort and noise incidental to

movement of the jaw. Such a procedure is evidently gaining popularity in the US but may not

have reached Canada yet. Major problems are expected if and when and if it does.

The document from which these quotations are extracted is one of the four the authenticity of which is been

questioned by the Defendant. For the purposes for which these quotations are used here, I point out only that these

were implants inserted into the knee and not as temporomandibular joint implants. The two knee implants are

discussed in a handwritten memo dated September 9, 1982 from P. Blais to Dr. M. T. Cooper (Exhibit 27 v. 1 T. 12

at p. 000069)

¹¹⁵Transcript of Pierre Blais (April 29, 2019) at p. 14 (Dissenter recorded in the transcript as “descenders” which I

take to be a typographical error.)

Page: 35

However, there were [dissenters] who were not within the community, who were

not within Health and Welfare who occasionally advocated that there were

potential useful applications for Proplast, but they were not National Health and

Welfare people.

[105] Who were they? The quotation immediately above is followed by:

They were individuals representing manufacturers associations. They were

individuals who might have presented in connection with a clinical trial, for

example, the hernia patch issue. There were people who may have been a third

party or agents acting on behalf of Vitek or Novamed, but these were not people

from National Health and Welfare. You could deem them to be promoters or

stakeholders, I think is the word we used, for the product.¹¹⁶

[106] In other words, they were the people interested in having the product come to market.

The same people who would have conducted any tests necessary to show that it could be used

safely and to the advantage of patients who were suffering.

[107] Can the attitude of Pierre Blais, demonstrated by the broad statements he made, be

explained or at least a context for understanding be identified? The controversy that surrounded

his departure from Health and Welfare Canada was not the first time he had run afoul of its

senior representatives. In April 1981, Pierre Blais was interviewed by a journalist working for

the Ottawa Citizen in respect of the use of DEHP [“di(2-ethylhexyl) phthalate¹¹⁷] in blood

transfusion products. He was quoted as saying that “those who give blood through

plasmapheresis… Could face a long-term risk of kidney or liver injury” and that “the use of

plastic containing DEHP is a senseless and unnecessary risk”¹¹⁸. Pierre Blais’ comments

generated considerable consternation among senior officials at Health and Welfare Canada. In a

memo dated May 4, 1981, addressed to the Director of the Medical Devices Bureau, the Director

General of the Environmental Health Directorate, Dr. Emanuel Somers, expressed his concerns

over Dr. Blais’ conduct:

Let me say that I regard Dr. Blais' performance to be alarmist, misleading, and, in

the final analysis, irresponsible. To elaborate, Dr. Blais is employed as a research

chemist to study and advise on the physical and chemical properties of

biomaterials and polymers. He has not the expertise or capability to advise on the

toxicology of chemical materials. That responsibility rests with the Bureau of

Chemical Hazards, whose staff comprise a number of experienced toxicologists

with the required knowledge and ability… Once again, Dr. Blais is pontificating

beyond his responsibility or expertise.¹¹⁹

¹¹⁶Ibid at p. 14

¹¹⁷Agency for Toxic Substances and Disease Registry, Division of Toxicology, Public Health Statement (September

2002): “A manufactured chemical that is commonly added to plastics to make them flexible.”

¹¹⁸Transcript of Pierre Blais (May 13, 2019) at p. 528

¹¹⁹Ibid at p. 52-528 and Exhibit 34, Tabs 11, 12 and 66

Page: 36

[108] There is a memo dated May 4, 1977. It is shown as being from “P. Blais, Materiaux De

Las Medecine” to “B.N. Thivierge, Chef Division Des Affaires Reglementaires”.¹²⁰It is one of

the four documents the authenticity of which was questioned by the Crown. The document along

with the other three where the issue was raised was subjected to forensic analysis by experts

employed by the Canada Border Service Agency in the Analytical and Forensic Services

Division, Science and Engineering Directorate. I begin by observing that regardless of whether

the document was “authentic”, which in the context of this case means that it was written on the

date shown on its face as opposed to sometime later, it would be of little probative value. The

document asked about the existence of files related to several stated subjects (“Sacs A Sang, Sac

Pour Parenteraux, I.V., Specimens, Notification”) and asked specifically whether the recipient

had a recollection of a file named “Silicone Injectable, Polytef and Proplaste”. The reference to

Proplast in a memorandum asking whether there is a file that includes in its name the word

Proplast does not help in understanding what was known or not known about material associated

with that word.

[109] The work done by the experts does not support a finding that the document was not

prepared on the date shown, for the purpose stated. The document is not typed. It is

“handprinted”. It has a handwritten signature above the printed name “P. Blais” and, in the upper

righthand corner, above the printed letterhead, “MEMORANDUM NOTE DE SERVICE”, it

has, in handwriting, words identified in evidence as “plastics site”. For the purpose of “Hand

printing Comparisons” the document is included in the first of two groups of documents being

examined. The conclusion respecting its authenticity, insofar as the hand printing is concerned,

was stated as:

Conclusion: this finding provides more support for the belief that the questioned

hand printing entries in Group 1 were written during the latter period of the

specimen hand printing from 1989 or later, rather than on the dates they are

purported to be produced. However, this support, while greater for the belief that

the writing is anachronistic than it being contemporary, is limited or weak.

This comparison was hampered, and the conclusion severely limited, by 1) the

small amount of specimen writing for the time period after 1989, and 2) the subtle

and variable nature of the features upon which the assessment is based which

creates significant uncertainty in the final conclusion.¹²¹

[Emphasis added]

[110] This document is dominated by the hand printing. Even so the experts go on to examine

the signature found above the hand printed “P. Blais”. Under the heading “Signature

Comparisons” this signature is dealt with in the second of two groups. The conclusion is as

follows:

¹²⁰Exhibit 27 T. 2 and Exhibit 73 T. 3

¹²¹Exhibit 74A (Forensic Laboratory Report 27 February 2019) at p. 37 of 84

Page: 37

Conclusion: This finding provides support for the belief that the questioned

signatures on Items Q1 [the document presently being considered]…were written

during the latter time period of the specimen signatures (2000 and after), rather

than in the time period of the earlier specimen signatures (1966-1991). The level

of support is considered to be strong.

The comparison and the conclusion were limited somewhat by the relatively small

amount of specimen material provided for the timeframe after 1991.¹²²

[Emphasis added]

[111] To place the noted concern (being the small number of specimens available for the period

after 1991) in context, the number of specimens relied on for the identified period are: two from

1991, one from 2000, one from 2005 and three from 2018. To put it differently, “After 1991” but

before 2018 there are only two specimens. The three from 2018 are all signatures by which

Pierre Blais swore to the accuracy of three affidavits that bear his name. The expert

acknowledged that this is an unusual circumstance. It is one which may lead a party to be more

attentive of the act of signing.

[112] The question being asked is a serious one. It is about the fundamental integrity of the

individual involved. I am not prepared to find, on a balance of probabilities, that this document is

anything other than what it appears to be.

[113] I feel obliged to make a further observation. This is not the only one of the four

documents being questioned which has little if any probative value in respect of the issues raised

in this case. None of them do. From this, one has to wonder why the Crown felt compelled to

continue with the issue of their authenticity. I asked about the purpose. The first time the

question was asked, counsel indicated concern for what this might say about the integrity of

Pierre Blais. When the issue arose again the Court was advised that there is a separate

application brought by the Plaintiff by which her counsel seeks to demonstrate that the Crown

destroyed documents presumably knowing them to be relevant to this case. Counsel for the

Crown expressed the view that any decision made in these reasons respecting this issue could

impact that further application. To the extent that the rationale for the inquiry into the

authenticity of these documents is the impact these reasons may have on a further application, it

is collateral to the matters of concern in this trial. If it is the only true purpose, it is improper. The

issue of the destruction of documents is not before the Court. To my mind, any findings made

here should not be taken as determinative of issues to be raised after what would be a more

complete evidentiary investigation specifically directed to those questions.

[114] There was some confusion as to what exactly Pierre Blais did upon his return from the

Gordon Conference. In an affidavit he swore on January 16, 2000 he deposed that “after my

¹²²Ibid at p. 38 of 84

Page: 38

return to Canada I wrote a proposal recommending the prohibition against materials like

Proplast/Vitek.” In this affidavit Pierre Blais goes on to say that he took his recommendation that

Proplast be prohibited to his superior, Dr. Ron W. Campbell, that “to the best of [his]

information knowledge and belief” Dr. Ron W. Campbell passed the recommendation on to the

Director of the Medical Devices Bureau, Dr. Ajit K. DasGupta, that on the same basis he

understands that Dr. Ajit K. DasGupta agreed with the recommendation and passed it on to Dr.

Emmanuel Somers, who according to the information, knowledge and belief of Pierre Blais

rejected the proposal. There is no document that would support this recollection. The Rules of

Civil Procedure, at the time this affidavit was sworn, as they do now, required that when a fact is

attested to on “information and belief” the source of that asserted knowledge is to be

“specified”¹²³It was not. The affidavit goes on:

The reasons for my proposal were included in the written material, which was part

of a Bureau proposal for amending the Medical Devices Regulations.

[115] There is a document directed to amending the regulations. It is entitled “A Need for

Enhanced Regulatory Control of Invasive Medical Devices.”¹²⁴It first appears in company with

a covering memo dated May 28, 1981.¹²⁵It does not mention the prohibition of Proplast

products. In cross-examination counsel tried to clarify the uncertainty. Counsel suggested that

the proposal for prohibition must be in some other document and Pierre Blais answered:

Q. So that, this, I take it, sir, is a different, because of the timing, a different

proposal or recommendation that you wrote…That's a different one than the one

we looked at that's dated, that's at Exhibit 27, tab 7, from 1981. This is a different

one. Is that right?

A. It -- what you're referring to is probably the first ancestor to the series of

memoranda of which you have one, what we have called the 1981 memorandum.

The -- there was -- we discussed a few minutes ago my preparation of documents

for Dr. Campbell to brief his superior, and it did -- that was the very first of the

documents which ultimately led to many others, including the last one on

ophthalmic products. It was the first ancestor.¹²⁶

[116] There is no series of documents as referred to. The one that was produced does refer back

to the Gordon Conference albeit five years later, as of May 28, 1981:

During the late seventies, Dr. Homsy and his associates made numerous

conference presentations and published a series of papers presenting Proplast

applications and the outcome of clinical studies. All conveyed information which

seemed contrary to basic medical and scientific principles. The findings also had

promotional overtones and were met with scepticism [sic]. At a 1977 conference

¹²³Rules of Civil Procedure R.R.O. 1990, Reg. 194 at R. 39.01(4) and (5)

¹²⁴Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4

¹²⁵Exhibit 27 v. 1 T. 7 and 73 T. 4

¹²⁶Transcript of Pierre Blais (May 10, 2019) at p. 479

Page: 39

of assembled biomedical leaders, pathologists and regulatory affairs specialists,

Dr. Homsy’s presentation was savaged by members of the audience.¹²⁷

[117] The document does not propose the prohibition of Proplast or similar products. Rather it

proposes the following:

In light of the present information, all Vitek, Proplast and Proplast-like implants

should be placed in a special category subject to close supervision by hospital or

professional ethics committees. If adverse events continue to be reported, the

product should be sequestered by the field operations directorate until the

regulatory status is clarified. A similar caveat should apply to any medical

implant based on graphite, glass or other high-performance fibers with or without

a consolidating matrix substance.¹²⁸

[118] Pierre Blais said, in his evidence, that this document was prepared as part of submissions

to be made to Treasury Board. This is confirmed by the covering of memo:

PLASTIC FLUID HANDLING SYSTEMS AND IMPLANTED DEVICES

Rationale for regulatory amendments

Following our discussions with Dr. DasGupta, I have updated the Divisions

rationale for regulatory amendments for our next Project Review.

As requested, I have added a discussion on countermeasures and regulatory

options. Expanded briefings can be drafted for TB [Treasury Board] submissions.

[119] The document appears more than once. Not only is it presented as of May 28, 1981, it

and the memorandum which encloses it, reappear. On the second version the typed date “May 28

1981” is struck out and replaced in handwriting by the date “Feb. 18, 82.” As explained by Pierre

Blais the document was used twice to assist in the preparation of the annual submission made to

the Treasury Board on behalf of the Bureau.¹²⁹The second version has a further handwritten note

asking “Linda” to have the file printed with large type “for Dr. DasGupta’s TB sub”.¹³⁰

[120] These submissions produced a positive result. They led to the amendments to the Medical

Devices Regulations that added to the Schedule to Part V any “new device” designed to be

implanted into the tissues or body cavities of a person for 30 days or more. As already noted, the

amendment was made on October 8, 1982 and became effective on April 1, 1983. Following a

review of the document I asked and Pierre Blais responded:

¹²⁷Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4 at p. 13. There was some confusion as to

whether the Gordon Conference took place in 1976 or 1977. In the end, despite what was said here, it was

determined to have been held in 1976.

¹²⁸Ibid at p. 14

¹²⁹Transcript of Pierre Blais (May 2, 2019) at p. 25-26

¹³⁰Exhibit 27 v. 1 T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4

Page: 40

THE COURT: All right. Now, looking not backwards from that but looking

forwards to where this went ultimately, ultimately, if I understand this correctly,

all of this concern leads in the end to the amendment in the regulation Part V in

1983, in which now we see these kinds of implants, implants that are going to be

input and last for more than 30 [days], becomes part of Part V.

A. Exactly.¹³¹

[121] As it turned out, these three documents, the two versions of the covering memorandum

and the paper, “A Need for Enhanced Regulatory Control of Invasive Medical Devices” are the

second set of documents where the authenticity is challenged. The primary concern with the

paper arises not from handwriting or hand printing but from the type face used. In the early

1980’s modern office machines were beginning to appear. However, Health and Welfare

Canada, as most offices of the day, still used typewriters. This was determined by a review of

documents produced at the time. Typewriters are distinguishable from more modern machinery

as impact printers: the paper is struck by a letter either on an arm or ball. Typewriters utilized

“mono spaced” print. The letters, regardless of their form, take up the same width. The letter “m”

takes up the same space as the letter “i”.¹³²More modern office machines use “proportional

spaced” print. The width of the letters varies.¹³³The printing on the documents was

proportionally spaced. The type face (font) was identified as Helvetica which had existed since

1961 and was based on designs that go back to 1957.¹³⁴This design was not seen on any known

documents with typewritten entries at Health and Welfare Canada.¹³⁵Glyphs (described as

“TM”

“R”

letter/character design) for example

and

were observed to be different from those of

Helvetica and other similar versions. The experts from the Canada Border Service Agency

concluded:

A Helvetica style of typeface was not seen on any known documents with

typewritten entries at Health and Welfare Canada.¹³⁶

[122] They went a step further; they searched typewriter databases to see whether the typescript

on the documents in question could be found in any proportional spacing typewriter. Such

spacing was not common in typewriters at the time. No typeface in any of the identified

classification systems were observed that corresponded to the typed entries being examined. The

glyphs ^“TM”and ^“R”were not commonly available in any typewriters from the time.¹³⁷The experts

found that:

¹³¹Transcript of Pierre Blais (May 10, 2019) at p. 483-484

¹³²Exhibit 74A (Forensic Laboratory Report 27 February 2019) at p. 58 of 84

¹³³Ibid at p. 59 of 84

¹³⁴Ibid at p. 18 of 84

¹³⁵Ibid at p. 19 of 84

¹³⁶Ibid p. 19 of 84

¹³⁷Ibid at p. 19 of 84

Page: 41

Accordingly, no features were observed to indicate that the typed entries depicted

on documents Q2 (1-22) were produced on any typewriter, at Health and Welfare

Canada or available elsewhere, in the time period in question.¹³⁸

[123] The forensic experts also examined the handwriting that appeared on the covering

memorandum. This includes the note asking “Linda” to print the document in larger script, the

handprinted date and the signature “P. Blais”. In each case the determination is the same. The

script tends to be consistent with the specimens of the date shown on the document: it is

“contemporary” rather than “anachronistic”. Thus, these results are different than those

associated with the typed script. However, as a result of the lack of later specimens from the later

time frame the experts do not foreclose the possibility that the hand writing was nonetheless

from a later date than shown on the face of the document.¹³⁹

[124] Obviously, this leaves the situation confused. The handwritten and printed script tends to

the documents being contemporary and the typed script to a later anachronistic date. The experts

acknowledged that while at the contemporary time the typed script was unlikely to have been

produced by a typewriter, there were “commercial printers” that were capable of producing the

script used. Work they had done to establish the equipment utilized by Health and Welfare

Canada, at the time contemporaneous to the dates shown on the face of the covering memoranda,

provided no indication that there was machinery available from contractors involved, who might

have had access to printers with the capacity to produce the script used.

[125] Although not a party to the action, Pierre Blais was examined for discovery. In the course

of this questioning Pierre Blais alluded to the possibility of the printing of these documents

having been done out of the normal context:

In 1982 the printing that you see in your hand is an alien printing. It comes from a

contractor or a machine that was not familiar to me. It was a wizardry of a

computer specialist who essentially reprocessed obsolete medium in order to

extract the original text.

[126] During that examination Pierre Blais referred to a company that he said had a contract

with what was then Health and Welfare Canada “for our word processing system”:

They produced software…and they produced customize systems for correlative

data at National Health and Welfare, and probably other departments as well.

They also did some kind of service on printers. And, they periodically, I think,

loaned us printers, including kinds that I’ve never seen before.¹⁴⁰

¹³⁸Ibid at p. 19 of 84

¹³⁹Ibid at pp. 35-36, 37 and 38 of 84

¹⁴⁰Transcript of the Examination for Discovery of Pierre Blais (February 5, 2019) at pp. 210-212

Page: 42

[127] Counsel for the Crown was quick to point out that, in the absence of the ability to cross-

examine Pierre Blais on these matters this evidence was, at best, hearsay.¹⁴¹However, the

question was not whether it should be accepted for its truth but whether it stood as a suggestion

the experts were aware of as they undertook their work. The forensic expert providing this

evidence was Tobin A. Tanaka. He had read some transcripts before coming to his conclusions.

It was his recollection that he had read of the individuals named in the transcript as associated

with the suggestion that an outside printer could have been involved. Neither he nor the other

expert, R. Brent Ostrum, had conducted any further investigation into this possibility. It was

beyond their mandate. Their concern was as to the physical properties of the documents not their

source, context or content.

[128] If I were required to do so, I would on a balance of probabilities, conclude that these

documents are authentic, that is they are as they appear. The main document “A Need for

Enhanced Regulatory Control of Invasive Medical Devices” is comprehensive dealing with far

more than just Proplast products. Pierre Blais proposed that there were many more versions but

there are only two that appear in the record (1981 and 1982). The two are consistent with the

stated purpose of assisting in demonstrating to Treasury Board that more was required to

properly regulate medical devices. This was apparent from both the overall subject matter and

the timing leading, as it does, to the amendments made on October 8, 1982 and made effective as

of April 1, 1983.

[129] As it is, the value of these documents as providing information supporting a position that

the accepted knowledge about Proplast was such that it should have led inexorably to a

conclusion that products using Proplast should never have been allowed into the market is

minimal if it exists at all. Why is this? It is because Pierre Blais, for all that he is relied on as the

beacon of this idea, acknowledged that amendments to the Medical Devices Regulations that

added implants that were to stay in the body for 30 days to those to be treated under Part V of

those Regulations was a sufficient response to the issues as he saw them. There is no document

demonstrating that a prohibition was ever asked for.¹⁴²There was no need for an absolute

prohibition whether or not one was ever proposed:

THE COURT: And I thought it was -- and you didn't say this before. I just sort

of remembered it when I was trying to work out in my own mind something that

you said. Remember that you said: When we ask for things, I dream; I ask for

everything that I could possibly want, and sometimes all I get is what I need. Do

you remember that?

A. Yes.

THE COURT: And I thought that maybe this fits that understanding of how this

works: You asked for a prohibition, didn't get it but got what you needed because

you got to examine the safety and efficacy of it?

¹⁴¹One of the people referred to “Barbara Goldhamer” was identified by Pierre Blais in his viva voce evidence albeit

for a different purpose (Transcript of Pierre Blais (May 1, 2019) at pp. 100-101)

¹⁴²Transcript of Pierre Blais (May 10, 2019) at p. 484

Page: 43

A. Yes. It was time when we accepted reality.¹⁴³

[130] In fact, it was what he had proposed in the document entitled “A Need for Enhanced

Regulatory Control of Invasive Medical Devices”:

Regulation Amendments are Inevitable

The present medical devices regulations enable inclusion of supplemental device

categories to the list of ‘high risk’ products. Accordingly, case-by-case addition of

specific product categories that embody risks at par or greater than those of the

present classes subject to the provisions of Part V. A timetable setting the date

when each of the new categories become subject to the new requirements would

then be proposed for comment by industry and consumer representatives.

Alternatively, a new set of classification criteria for devices subject to Part V

requirements could be created. It is noteworthy that all, except one, device classes

presently comprised under terms of Part V are implants. …

[131] This was followed by a proposal for the classes of devices that could be added to Part V.

The first of which was:

Missing Major Classes

All of the presently-listed Part V device categories and most classical implants of

other types would be captured under the term “implant”. Thus, a device intended

to be inserted in tissue or a body cavity or expected to be in intimate body contact

for an indeterminate period would become subject to the provisions of Part V. The

issue of contact time is moot. A large body of research and retrospective clinical

studies have demonstrated that direct contact with a faulty device for about a

month is sufficient to impart severe damage to user exposed to an injurious device

that does not have an essential physiologic or mechanical function. The presently

cited “30 day” watershed exposure would thus be retained.¹⁴⁴

[132] This offered the public a level of protection:

THE COURT: Okay, just a minute. So dreaming or dreams includes the

understanding that there would always be a limit on what the regulations would

allow, which I take to mean that there was an acknowledgment that there were

other considerations that regulators would bring to bear on the question which

would probably mean you would not get exactly what you wanted in terms of

regulatory power.

A. Yes, absolutely correct.

¹⁴³Transcript of Pierre Blais (May 13, 2019) at p. 633

¹⁴⁴Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4 at p. 2

Page: 44

THE COURT: All right. And then what you needed was for what you said was

minimal protection, therefore it was something less than the dream, but something

that would provide you with some level of regulatory authority to provide for

some level of protection to the public.

A. Yes.¹⁴⁵

[133] It was a compromise:

THE COURT: Okay, from which I deduced that -- and I'm asking now -- that

what we have here, as you have now described it, is an appearance of a concern,

the evolution of that concern into fear, and a process by which the various

competing points of view worked, ultimately winding up at what you've called a

compromise, which was, in effect, the 1983 inclusion of the 30-day rule, which

would have taken in Proplast and any consideration of it?

A. Exactly.¹⁴⁶

[134] Pierre Blais acknowledged this was typical of how amendments to regulations came to

be. He was asked:

THE COURT: So I want to say again and make sure I have this established with

you, that this is something you understood at the time, that this was a typical

evolution of a regulatory change.

A. Exactly¹⁴⁷

[135] This is not evidence that demonstrates a dedication to the prohibition of Proplast products

but rather the expression of concern, the acceptance of that concern and, in time, the arrival at

what was accepted as an appropriate regulatory response.

[136] The document (“A Need for Enhanced Regulatory Control of Invasive Medical Devices”)

was put to Janice Hopkins. She had been employed at Health and Welfare Canada from 1969 to

1979. She left and went to the Department of Fisheries and Oceans. She returned during 1980 as

the Director, Atlantic Region (Halifax). From 1982 to 1985 she was the Director of Management

Processes working in the Assistant Deputy Minister’s office. She was responsible for, among

other things, how resources were allocated. She and her staff provided the rationale to be put to

Treasury Board for the requests being made. Janice Hopkins does not recall the document (“A

Need for Enhanced Regulatory Control of Invasive Medical Devices”). It needs to be

remembered that she only returned to Ottawa during 1982. More importantly, the evidence

provided by Janice Hopkins confirms the thrust of that paper to the effect that more resources

were required to properly regulate medical devices and their entry into the market in Canada. She

¹⁴⁵Transcript of Pierre Blais (May 1, 2019) at p. 20

¹⁴⁶Transcript of Pierre Blais (May 10, 2019) at p. 486

¹⁴⁷Transcript of Pierre Blais (May 14, 2019) pp. 632-633

Page: 45

identified the minutes of a meeting of the Cabinet Committee on Social Development held on

March 4, 1981, prior to her moving to Ottawa in 1982.¹⁴⁸Apart from the members of Cabinet,

staff from several of the interested government departments were present. This included four

people from Health and Welfare Canada including “Mr. E. Somers” who Pierre Blais said turned

back his recommendation that Proplast be prohibited.

[137] The Committee had for consideration a Memorandum dated February 3, 1981 and

Discussion Paper of the same date, submitted by the Minister of National Health and Welfare,

recommending increased resources for the Medical Devices Program to permit it to more

adequately carry out its responsibilities under the Food and Drugs Act.¹⁴⁹The Minister of

National Health and Welfare opened the discussion. She began by…

… answering a question posed earlier by the Ministry of State for Social

Development regarding other options for dealing with the problem of regulating

the safety and efficacy of imported medical devices. She explained that her

department already uses information from United States regulatory agencies, the

Canadian Standards Council and other reliable agencies but that this alone is

inadequate for improving controls to the necessary level. The proposed approach

is sufficient to deal with the most dangerous devices and usage abuses, but given

the very large number of devices imported from over 30 countries, the rapid rate

of technological change and the sophistication of the technology, it will always be

impossible to check every device type. The provinces help to some degree by

certifying use of certain devices within their territory, but sharing of the work of

testing devices and setting standards could result in fragmented standards and a

fragmented market. She asked to be excused from the study of options requested

by the ministry, since she is satisfied that there are no practical options and that

the only means of reducing expenditures would be to impose a user fee. This

could increase healthcare costs.¹⁵⁰

[138] The Discussion Paper under the heading “RECAPITULATION” summarized the

recommendation being made:

The main points raised in the foregoing are:

Medical devices are essential for modern healthcare but many sold in Canada are

hazardous or ineffective and cause avoidable health or injury.

The Department of National Health and Welfare is responsible under the Food

and Drugs Act for ensuring that manufacturers sell only safe and effective

devices.

¹⁴⁸Exhibit 55 at T. 3

¹⁴⁹Ibid at T. 3, p. 15 and respectively at T. 1 and T.2

¹⁵⁰Ibid at T. 3, p. 15-16

Page: 46

The Department is unable to fulfil this responsibility adequately with present

resources.

Regulatory control of devices in Canada must cope with the unusual situation

arising from the lack of domestic manufacturing the high dependence and demand

for technology by the healthcare delivery system.

A collaborative strategy involving the government, manufacturers and users,

tailored for the Canadian situation, is proposed. This requires 20 PY [person

years] in 1981-82 and an additional 14 PY in the following year for a total of 34

PY to:

(a)

(b)

(c)

Ensure reasonable probability of safety and effectiveness of the

highest priority inventions before open marketing;

develop essential performance and safety standards and testing

capability; and

take corrective and preventive actions in response to report of the

most severe device failures.¹⁵¹

[139] The proposal for a collaborative strategy involving the government, manufacturers and

users was accepted. The Record of Cabinet Decision, dated December 8, 1981, noted:

8. Medical Devices Program

(1) the proposal be approved but the question of additional person years be

considered by the Treasury Board;

(2) the Minister of National Health and Welfare be requested to develop an

overall policy on the question of allocation of costs in relation to testing the safety

of drugs and devices and to report back to the Committee within a year.¹⁵²

[140] The need for additional person years was recognized, the costs acknowledged but

approved. The approval was explained in a letter to the Deputy Minister dated February 24,

1982:

Dear Mr. Fry:

Your minister’s submission seeking resources for an expanded program testing

and evaluation of medical devices was re-considered by the Treasury Board on

February 11, 1982. In addition to the approvals given by the Treasury Board at its

¹⁵¹Ibid at T. 2 (Discussion Paper) at pp. 21 and 22

¹⁵²Ibid at T. 4 (Record of Cabinet Decision) at p. 5

Page: 47

meeting of July 23, 1981, as contained in my letter of July 30, 1981, Ministers

approved the following:

(a)

inclusion of an item in Supplementary Estimates 1982-83 of 20 person-

years and associated salaries of $503,000 for the medical devices program;

and

(b)

an increase in your departments reference levels of 34 person-years and

associated salaries of $855,000 in 1983-84 and subsequent years.

Ministers requested the department to report to the Treasury Board no later than

January 1984 on the appropriate level of service for the medical devices program,

based on information available at the time.

Yours sincerely,¹⁵³

[141] This approach and these considerations demonstrate a recognition of the concerns

associated with the regulation of medical devices. These actions were a substantial effort to

adjust the approach and provide appropriate resources not just with respect to Proplast products

but the broader concern for medical devices at large. This is consistent with the document “A

Need for Enhanced Regulatory Control of Invasive Medical Devices” the content of which went

beyond concern for a single product type and proposed solutions within the regulatory scheme as

opposed to an absolute prohibition of Proplast products. With the October 8, 1982 amendments

in place, the regulatory approach can be seen as collaborative. It relies on:



the manufacturers and distributors to undertake the necessary testing,

the government to consider whether, based on the information provided, a

reasonable probability of safety and efficacy has been demonstrated for the

highest priority inventions (i.e. those to which Part V apply), and



users (doctors, hospitals and patients) to report on difficulties that may appear.

[142] The decision to adopt a collaborative approach was an important one, made at a crucial

moment in the evolution of the policy governing the treatment of medical devices. It is a decision

that informed, modified and explains what happened thereafter in connection with the regulation

and regulatory activity that affected this area of concern.

[143] Those efforts did not stop with those amendments becoming effective as of April 1, 1983.

The record of this trial includes a document dated February 1985, entitled:” Medical Devices

Program, Health Protection Branch, Department of Health and Welfare, Workload Submission”.

It is a proposal to obtain approval to include in the 1985-1986 Supplementary Estimates

¹⁵³Ibid at T. 6

Page: 48

increased funding to allow delivery of the approved minimum level of service for the Medical

Devices Program.¹⁵⁴

[144] This is not to say that over time, from time to time, government demands did not require

adjustment to the resources made available. A letter dated September 26, 1985, from the Minister

of Health and Welfare Canada to the President of the Treasury Board is a case in point. It does

not deal specifically with medical devices. It reads in part:

The updated Multi-Year Operational Plan for my Department is being forwarded

to the Treasury Board Secretariat. As requested this plan incorporates our detailed

proposals for reducing our person-year (PY) requirements over the next five-year.

To achieve the targets proposed to us by the Treasury Board Secretariat.

…

As will be seen in the detailed plan, we have been able to identify a variety of

person-year reductions which will enable us to meet our targets. Indeed, we have

identified possibilities for PY reductions which are considerably in excess of our

targets.

[145] The same letter maintains the concern of the ability of Health and Welfare Canada to

have the resources necessary to undertake its responsibilities:

The MYOP also identifies those areas where we require additional resources to

meet unavoidable workload increases, to carry out new governmental decisions,

and to cover increases in the costs of maintaining a non-discretionary level of

service.

…

However, I do have to put on the record the fact that I am able to offer reductions

of this magnitude only on the understanding that new resources would be made

available to enable me and my Department to meet essential requirements for

which there is no provision in current reference levels, whether these arise from

new government decisions or from unavoidable workload increases. Without this

understanding, clearly I could not make all these cut-backs from departmental

person-year resources, because it would become essential for me to divert

resources to other requirements.¹⁵⁵

[146] This followed a one-person year cut imposed on the Environmental Health Directorate of

which the Bureau of Medical Devices was part, effective April 1, 1984. Of this a 0.33 PY cut

was allocated to the Bureau. At the same time a similar cut of 0.33 PY “temporarily” for the last

¹⁵⁴Ibid at T. 9

¹⁵⁵Ibid at T. 13

Page: 49

few months of 1983-1984 was extended indefinitely.¹⁵⁶To my mind, these are small changes

made in response to policy adjustments that mark the constant evolution of government

priorities. They do not signify any change in the commitment to, or inadequate support for, the

regulation of medical devices.

[147] Through the early 1980’s the regulatory scheme was amended to meet the challenge

posed by the increased interest in, development of and demand for medical devices. The

changes, while not what Pierre Blais says he “dreamed of” as the response to products that

included Proplast, were sufficient to allow for protection of the public. What was the general

understanding of the utility of Proplast and the medical devices in which it was included? It was

not universal acceptance that it was dangerous or that any harm associated with it outweighed

any benefit. In 1983 a book was published¹⁵⁷: “Biomaterials in Reconstructive Surgery.” The

book was edited by Dr. Leonard R. Rubin. Some of his credentials are listed on fronting page of

the book: for example, “Diplomate, American Board of Plastic Surgery; Clinical Professor,

Plastic Surgery, State University of New York, Stony Brook and Director, Plastic [and]

Maxillofacial Surgery and Burn Center, Nassau County Medical Center, East Meadow.¹⁵⁸The

book was described by Pierre Blais as a “teaching textbook on plastic surgery.”¹⁵⁹

[148] Pierre Blais explained to the Court that he had worked with Leonard R. Rubin at the

facilities of the State University of New York in relation to a Proplast chin implant.¹⁶⁰He said

that work demonstrated that part of the Proplast implants had disintegrated and scattered over

about a half-inch of tissue. The implant was surrounded by a layer of pus.¹⁶¹This information

was conveyed to his superiors at Health and Welfare Canada “between ‘79 and ’80;”¹⁶²which is

to say years before the book was published and before the amendment to the Medical Devices

Regulations which added these implants to those devices being treated by Part V.

[149] Leonard Rubin is shown as the author of Chapter 30 of the book, the chapter in which the

work of Pierre Blais is reviewed.¹⁶³It refers to the observation of two patients with mandibular

implants: one placed for 32 years the other for 18 years. These were the tissues evaluated by

¹⁵⁶Ibid at T. 9, p. 6

¹⁵⁷Pierre Blais first testified that the book was published in 1981 (Transcript of Pierre Blais (May 1, 2019) at p. 98)

but the book itself bears the date 1983 (Exhibit 34 v. 1 T. 17 and T. 19) and Pierre Blias subsequently agreed it was

published in 1983 (Transcript of Pierre Blais (May 3, 2019) at p. 404)

¹⁵⁸The complete list found on the fronting page includes: “Attending Plastic Surgeon, Nassau Hospital, Mineola and

Mercy Hospital, Rockville Centre; Honorary Plastic Surgeon, North Shore University Hospital, Manhasset, New

York [and] 1978 Chairman of Gordon Research Conference in Biomaterials.”

¹⁵⁹Transcript of Pierre Blais (May 1, 2019) at p. 98

¹⁶⁰Transcript of Pierre Blais (May 3, 2019) at pp. 399-400

¹⁶¹Ibid at p. 401

¹⁶²Ibid at p. 402

¹⁶³Exhibit 34 v. II T. 98

Page: 50

Pierre Blais. The implants used polyethylene, not Proplast. Pierre Blais acknowledged the work

he did, that is reported in the book, does not consider any Proplast product.¹⁶⁴

[150] To the contrary, insofar as Proplast is concerned, the book suggests something quite

different.

[151] Chapter 31 of the book is entitled “Clinical uses of Proplast: expectations and results”

Pierre Blais said he reviewed the chapter and prepared a critique. He “may have” a copy it but it

was not produced.¹⁶⁵The results of the studies reported in this chapter include:

The extensive amount of experimental animal studies that preceded its use in

humans included the usual small laboratory animals as well as canine and primate

implantations, which later were followed in a few cases much longer than the

usual [illegible] period under the direction of the original experimenters who

continued their observations to their clinical usages. The continued clinical

observation of the implants has allowed interim biopsies, which were quite

desirable. A collation of a total series reported to the manufacturer’s lead to a

review of a series of 900 clinical implantations with the rejection rate of less than

2%.¹⁶⁶

…

Our histological review of these implants and their capsules have shown that all

the implants are surrounded by pore spaces invaded by multinucleated giant cells.

However, we have noted that the population of the giant cells seemed to diminish

with prolonged fibrous tissue in growth though this is based on segmental

biopsies of clinical patients rather than total removal of the implant and its

surrounding tissue reaction for study. Nonetheless, in a few patients because of

gross irregularity or too large a prosthesis, large sections were removed and

studied after several years of insertion and they confirmed the experimental

findings in those primates studied for a period from 3 to 5 years-firm in growth

with adequate fixation.¹⁶⁷

…

Surface fragmentation

There is surface fragmentation, and when the material is examined under a

microscope (Fig. 31-4), one would expect this of a fiber-felt multi-open pored

implant. Bits of surface fragmentation have been found as inclusions in

multinuclear giant cells (Fig. 31-5) nonetheless, the implants have clinically

¹⁶⁴Transcript of Pierre Blais (May 3, 2019) at pp. 409-410

¹⁶⁵Exhibit 34 v. I T. 19

¹⁶⁶Transcript of Pierre Blais (May 13, 2019) at p. 585

¹⁶⁷Exhibit 34 v. I T 19 at pp. 494-495

Page: 51

maintained the initial contour with no clinically palpable detection of the minimal

fragmentation or migration of material. Darkening of the skin, in superficial

locations, such as the nose, the periorbital region, or any area with scar covering

or thin overlying skin with little subcutaneous tissue, by black phagocytized

material has appeared in the dermis can be progressive. This is believed to be a

significant problem in and around the thin tissues and after superficial removal

reoccurrence has been noted, requiring not only the substitution of the Proplast I

with other materials but also, on two occasions, resection of the surface covering.

The migration of material has [illegible] sufficiently serious around the nose and

the periorbital region and one chin to necessitate total removal of implant and its

surrounding fibrous tissue and its initial replacement with either a dermis or

superficial that flap followed at a later date by implementation of other

material….¹⁶⁸

…

SURVEY OF CLINICAL USAGES

The clinical experience over the past 10 years has been reviewed in an ongoing

accomplice and report on more than 900 human implantations with Proplast I that

were carried out internationally by surgeons of various backgrounds using varying

techniques and with varied methods of implant and recipient site preparation. The

use of the implant material was preceded by a 5-year intensive experimental study

of the biocompatibility of Proplast varying anatomic areas and many different

animals, from mice to primates, as well as continuing and repeated studies

biocompatibility in with tissue cultures. In 1973, “The Clinical Use of a New

Porous Implant: Proplast”,” a review of a five-year serial studies of this material

in baboons, was presented to the Association of Plastic Surgeons. In 1975 a 4-

year ongoing clinical study of human Proplast implantations included alveolar and

maxillary augmentation, coating of self-stabilizing condylar prostheses,

mandibular augmentation, soft tissue replacement and reconstruction of costal,

sternal, facial and cranial bone deformities. A survey conducted by Kent et al.,

presented at the International Biomaterials Congress in April 1980, reviewed 700

patients and demonstrated “immediate and delayed” success rates well in excess

of 90%. The literature of the past few years contains reports by experienced

plastic surgeons, maxillofacial surgeons, otolaryngological surgeons, oral

surgeons, and even ophthalmological surgeons, as to the uses and proposed use of

Proplast I. Although all the ophthalmological clinical trials were experimental,

Proplast was well tolerated as implants in the cornea and skilled era and obviously

a good deal has yet to be studied, including the rate of post-tissue in growth in the

long-term acceptance of the alloplast….¹⁶⁹

¹⁶⁸Ibid at pp. 498-501

¹⁶⁹Ibid at p. 501

Page: 52

…

SUMMARY

Proplast has fulfilled to a large degree the criteria that were planned in its original

development; it has a minimal reactivity and is thermostable, and the surface

porosity allows penetration by the adjacent fibroblasts and a certain amount of

tissue fixation. Although relatively easy to shape, there are problems involved

with irregularities, possible feathering of edges, which may, at a later date, flare.

But its low elastic modulus is sufficient to allow gentle massage and external

compression though direct incision and revision of the implant has been carried

out. Except for the one case mentioned, our incidents of infection has been

extremely low. We have had implants that have developed seromas around the

larger sections, possibly because of rib-cage motion during breathing but

eventually tissue fixation has been excellent. We have not seen fixation correlate

with deep penetration, nor have we seen even the long-term cases show a good

bony scaffold. There has been a tendency to fragmentation of the surface with

encapsulation of particles by macrophages, which seem to have migrated to the

dermis. To date this has only been apparent in the superficial dictations below thin

skin flaps or adjacent thin scars. It may be that the light-colored Proplast II may

satisfactorily eliminate this problem, but a further long-term follow-up study is

necessary….¹⁷⁰

[152] This chapter and the studies to which it refers do not confirm that by the early 1980s

there was an understood and comprehensive conclusion that any harm caused by the

implantation of Proplast products would inexorably outweigh the benefits that could be achieved.

[153] The chapter in which this appears was written by Charles Homsy, the developer of

Proplast. Given his expressed concerns, Pierre Blais was asked why the editors of the book (he

was one of them) decided the chapter was worthy of inclusion. The reason? Maybe Charles

Homsy was right:

…collectively in consensus, we decided to err using the logic that was presented

by His Honour. We reasoned: What if Charles Homsy were right; therefore give

him a springboard or maybe a point to express his views and let the rest take place

as it should. We left it to the reader to decide for themselves. That was the

consensus.

THE COURT: But it raises the prospect that it was still believed by the group as a

whole, maybe not all the individual members, that it was still possible that Homsy

was right.

¹⁷⁰Ibid at pp. 507-508

Page: 53

A. Yes.¹⁷¹

[154] According to Pierre Blais this happened well before the book was published. The

decision was taken in 1979, still after the furor Pierre Blais says took place, at the Gordon

conference, in opposition to Charles Homsy.

[155] Dr. Doran Ryan is an American maxillofacial surgeon. He is a teacher and frequent

speaker on the subject. Doran Ryan provided evidence as to the history of the effort to deal with

problems associated with the temporomandibular joint. 1982 was a significant year. There were

advances in the applicable radiology. It had not been possible to inject dye into an area as small

as the temporomandibular joint. This became feasible in 1982 making it easier to identify the

kind of problems involved. Prior to this advance it was difficult to identify the problem when

patients complained of pain or discomfort. In some cases, it was thought to be purely

psychological. In others, more conservative treatment was used: muscle relaxants, anti-

inflammatory drugs, painkillers and other areas of expertise such as neurology. Even with the

improved imaging these “modalities” were still used. Some surgical treatments were undertaken.

Doran Ryan referred to “Dr. Brown” who was taking out the meniscus with a high degree of

success. He had about a 20% failure rate. Beginning in or around 1963, surgeries were

undertaken, where part of the bone was removed and replaced with a block of solid silicone

(described as “gap arthroplasty with implant”). In 1980, efforts were made to reposition the disc.

When it became apparent that repositioning the disc, after displacement, was not always

possible, the disc was removed and solid silicone sheeting used as a replacement. This was

expected to last for years. However, silicone did not have sufficient strength and tended to tear.

A different solution was needed.

[156] As reported by Doran Ryan, the first published results regarding Vitek Proplast Block as

an interpositional implant appeared in 1982, when for example Kiersch reported a 93% success

rate over nine years for 250 implants:¹⁷²

No, no. Vitek did the studies. They have files, a mechanical engineer that did

those studies, and that's what they had. And they also had -- by the time I used

that product in [1983],¹⁷³they already had nine years of experience implanted in

the patients as produced by Kiersch in his study in [1984] that he presented. So,

I'm looking at nine years of history of the product implanted in patients, and also

looked at their bench studies they did on wear of the product…¹⁷⁴

¹⁷¹Ibid at p. 614.

¹⁷²Exhibit 51 T. 10 (Ryan, Doran E: Alloplastic Implants in the Temporomandibular Joint, Oral and Maxillofacial

Surgery Clinics of North America-Vol. 1, No. 2, December 1989) at p. 428

¹⁷³The transcript does not say 1983. It says 1993. The evidence of Doran Ryan was clear. He placed Vitek Proplast

implants from 1983 to 1985. By 1987 he had “explanted” all of these implants. It is my assumption that the

transcript contains a typographical error. In the transcript the Kiersch study is referred to as reported in 1994. The

citation for that study is: “Kiersch TA. The use of Proplast-Teflon implants for meniscectomy and disc repair in the

temporomandibular joint [Abstract]. Presented at the AAOMS Clinical Congress on Reconstruction with

Biomaterials, San Diego, 1984”. Again, I believe the reference to 1994 is a typographical error.

¹⁷⁴Transcript of Doran Ryan (June 4, 2019) at pp. 10-11

Page: 54